[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-volunteer-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-volunteer-study":405},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,51,82,113,134,155,176,201,227,247,270,299,326,350,378],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100641361",false,"NCT07660731","A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma","A PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, RELATIVE BIOAVAILABILITY, FOOD EFFECT, METABOLISM & EXCRETION, AND DRUG-DRUG INTERACTION POTENTIAL OF PF-08103402 IN HEALTHY ADULTS AND\u002FOR ADULTS WITH MILD TO MODERATE ASTHMA","Key Inclusion criteria (Parts A, B, C, D and F):\n\n1. Are males or females who can no longer have children,\n2. Are 18 to 65 years old,\n3. Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nFor Part A (Optional group or cohort 3: Japanese participants only):\n\n1. A total body weight of more than 45 kg (100 pounds).\n2. Have 4 biological Japanese grandparents who were born in Japan.\n\nFor Part E only:\n\nAdults with a documented doctor's-diagnosis history of asthma for at least 12 months before entering the study.\n\n1\\. Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nKey Exclusion criteria\n\n1. Evidence or history of clinically significant medical conditions.\n2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).\n3. History of alcohol abuse or binge drinking and\u002For any other illicit drug use or dependence within 6 months of Screening.\n4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.\n5. Any history of parasitic infection requiring treatment within 28 days prior to screening.\n6. Positive tuberculosis infection test result.\n7. Part C only: Evidence or history of conditions interfering with the ability to taste.\n8. Part D only: History of irregular bowel movements.\n9. Part E only: Evidence of lung disease(s) other than asthma.\n10. Part E only: Asthma exacerbation within 3 months prior to screening.\n11. Part F only: History of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis or adverse reaction to midazolam or other benzodiazepines.",true,"ALL","18 Years","65 Years",{"count":20,"type":21},139,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people.\n\nFor Parts A, B, C, D and F, the study is seeking participants who:\n\n* Are healthy (do not have disease) males or females who can no longer have children,\n* Are 18 to 65 years old,\n* Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight\n\nFor Part A (optional group or cohort 3: Japanese participants only):\n\n* A body weight of more than 45 kilograms (100 pounds).\n* Have 4 biological Japanese grandparents who were born in Japan.\n\nFor Part E only:\n\n* Adults with a documented history of asthma (confirmed by a doctor) for at least 12 months before entering the study.\n* Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nThe study has six parts: Part A, Part B, Part C, Part D, Part E and Part F. The study medicine will be taken as a suspension or tablet by mouth 1 time a day (except in Parts B and E where it will be taken 1 time a day for 14 days) at the study clinic. The study will help understand:\n\n* how the body processes the study medicine in healthy participants (Parts A and B),\n* how much of the study medicine gets into the bloodstream and if food affects the amount of study medicine in the blood in healthy participants (Part C),\n* how the study medicine is broken down and leaves the body in healthy participants (Optional Part D),\n* how the study medicine is processed in adults with mild-to-moderate asthma (Optional Part E),\n* if taking the study medicine together with another medicine affects how each medicine is processed by the body in healthy participants (Optional Part F).\n\nParticipants will take part in the study for about 10 weeks (Parts A and F), 12 weeks (Part B), 9 weeks (Parts C and D), and 16 weeks (Part E).\n\nDuring this time, they will have 2 study visits at the study clinic and up to 28 overnight stays (Part A), 18 overnight stays (Parts B and E), 10 overnight stays (Part C), 11 overnight stays (Part D), and 16 overnight stays (Part F). The study team will also call participants 1 time over the phone at the end of the study to assess how they are doing.\n\nStudy measurements will be taken by body examination, monitoring side effects, blood and urine tests, heart tests (ECG), vital signs (blood pressure and pulse), questionnaires (Parts C and E), stool samples (Part D only), and breathing tests (Part E only).",[27,28,29,30],"Healthy Volunteer Study","Healthy Adults","Healthy Participants","Asthma",[32,33,34,35,36,37],"Human","Randomized","Metabolism","Excretion","Drug-Drug Interaction","Food effect","RECRUITING","2026-06-24",{"date":41,"type":42},"2026-06-29","ACTUAL",{"date":44,"type":42},"2026-06-17",{"date":46,"type":21},"2027-06-18",{"name":48,"class":49},"Pfizer","INDUSTRY",1,{"id":52,"slug":4,"hasResults":10,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":15,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":50},"100594563","NCT07021079","Muscle Vibration as a Countermeasure Against Hypoactivity-induced","Effects of Focal Muscle Vibration as a Countermeasure Against Hypoactivity-induced Neuromuscular Deconditioning","NEUROVIB-ULLS","Inclusion Criteria:\n\n* Men and women.\n* Aged 18 to 45 years.\n* Body Mass Index (BMI) between 18,5 and 24,9 kg\u002Fm².\n* Engaging in at least 1.5 hours per week of physical activity (e.g., brisk walking, running, swimming, cycling).\n* Provided informed consent after receiving detailed information about the study.\n* Affiliated with or beneficiaries of a social security system\n\nExclusion Criteria:\n\n* Chronic cardiovascular, neuromuscular, bone, metabolic, and\u002For inflammatory disorders.\n* Personal history and\u002For risk factors for thrombosis.\n* Use of antidepressant medications.\n* Use of neuroactive substances likely to alter corticospinal excitability (e.g., hypnotics, antiepileptics, psychotropics, muscle relaxants) during the study.\n* Recent bone or ligament trauma within the past 12 months.\n* Inability to perform the physical efforts required for the study.\n* Recent participation in a sporting competition or intense, unusual physical activity within the past month.\n* Corticosteroid treatment within the past 3 months.\n* Any skin lesions at the planned vibrator application site.\n* Simultaneous participation in another interventional medical study.\n* Pregnant or breastfeeding women.\n* Individuals unable to understand the purpose and conditions of the study or unable to provide informed consent.\n* Individuals deprived of liberty or under guardianship","19 Years","45 Years",{"count":61,"type":21},42,[63],"NA","Muscle deconditioning, characterized by a loss of muscle mass and strength, is a frequent consequence of prolonged lower limb unloading. Beyond muscle mass loss, reduced neural drive contributes significantly to strength decline, highlighting the need for interventions targeting neuromuscular function during immobilization. Focal muscle vibration (FMV) has shown promise in modulating neuromuscular excitability by activating muscle spindle afferents and inducing cortical adaptations. Chronic use of FMV has been associated with significant strength gains and improved neural command. This makes FMV an effective rehabilitation tool. Its simplicity and non-invasiveness further make it a practical countermeasure.",[66,27,67],"Vibration Therapy","Hypoactivity",[69,70,71],"hypoactivity","neuromuscular deconditionning","Vibration","2026-05-22",{"date":74,"type":42},"2026-05-26",{"date":76,"type":42},"2025-06-16",{"date":78,"type":21},"2027-08-31",{"name":80,"class":81},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",{"id":83,"slug":4,"hasResults":10,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100637582","NCT07600814","Pain Induced by m-Cresol as Preservative","Pain Induced by m-Cresol as Preservative - A Randomised Controlled Crossover-Trial in Healthy Volunteers","Inclusion criteria\n\n* Age between 18 and 70 years\n* Full legal capacity Exclusion criteria\n* Participant of another study, ongoing or within the last four weeks\n* Current medication intake (except hormonal contraception) or drug abuse\n* Female subjects: Positive pregnancy test or breastfeeding\n* Body temperature above 38°C, verified by infrared thermometer\n* Known allergic diseases, in particular asthmatic disorders and skin diseases\n* Sensory deficit, skin disease or hematoma of unknown origin in the examination of the test site","70 Years",{"count":90,"type":21},18,[92],"EARLY_PHASE1","Preservatives such as m-Cresol are essential components in many subcutaneously injected medications, including insulin or human growth hormone, to prevent bacterial growth. However, clinical reports have suggested that these preservatives may cause local discomfort or pain at the injection site, which can negatively impact treatment adherence. While m-Cresol is widely used, its direct contribution to injection-site pain has not yet been investigated in a prospective clinical trial.\n\nThis study aims to investigate whether subcutaneous injection of m-Cresol at concentrations commonly used in clinical practice (0.1% and 0.25%) cause significantly more pain than a preservative-free control solution. In a randomized, double-blind crossover design, healthy volunteers will receive three separate injections in a belly fold. Participants will rate their pain every 5 seconds until it subsides. The findings will help determine if m-Cresol is a primary source of injection-site pain and could lead to the development of more comfortable drug formulations.",[95,96,27],"Pain","Acute Pain",[98,99,100,101,102,103],"m-Cresol","Preservative","Subcutaneous Injection","Human Pain Models","Experimental Pain Models","Nociception","NOT_YET_RECRUITING","2026-05-15",{"date":72,"type":42},{"date":108,"type":21},"2026-05-25",{"date":110,"type":21},"2026-06-08",{"name":112,"class":81},"Medical University of Vienna",{"id":114,"slug":4,"hasResults":10,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":50},"100504362","NCT05847322","Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks","A Human Controlled Infection Study to Establish Safety of Infection With Bordetella Pertussis With Antibiotic Therapy Delayed for up to 6 Weeks","Inclusion Criteria:\n\n* Healthy adults aged 18 to 55 years inclusive on the day of screening\n* Fully conversant in the English language\n* Able to communicate easily by both mobile telephone, email and text messaging\n* Able and willing (in the investigator's opinion) to comply with all study requirements\n* Written informed consent to participate in the study\n* Willingness to take a curative antibiotic regimen if \u002F when required according to the study protocol\n* Willingness to abide by infection control guidelines during social contact for the duration of their participation in the study\n* Willingness to attend to the National Institute for Health Research (NIHR) Clinical Research Facility (CRF) Southampton immediately if they become symptomatic\n* Agreement to have no bedroom contacts other than their corresponding contact\u002Fchallenge volunteer between inoculation and 6 weeks after inoculation\n* Able to answer all questions on the pre-consent questionnaire correctly\n\nExclusion Criteria:\n\n* Individuals living in the same households as:\n\n  1. unimmunised or partially immunised children and infants aged \\\u003C 1 year\n  2. pregnant women \\>32 weeks who have not received pertussis vaccination at least a week prior to contact\n  3. immunosuppressed individuals\n  4. frail individuals\n  5. healthcare workers regularly working with vulnerable individuals as above\n* Individuals who have inviolable commitments within the study period (from day 0 to week 6 + 2 days) to be in close contact with:\n\n  1. unimmunised or partially immunised children and infants aged \\\u003C 1 year\n  2. pregnant women \\>32 weeks who have not received pertussis vaccination at least a week prior to contact\n  3. immunosuppressed individuals\n  4. frail individuals\n* Individuals who live in a boarding school or dormitory during the study.\n* B. pertussis detected on nasal wash taken before the initial challenge\n* Individuals with a confirmed or suspected infection at the time of inoculation with B. pertussis\n* Individuals who have participated in other interventional clinical trials in the last 12 weeks\n* Individuals who have a history of receiving B. pertussis vaccination in the last 5 years\n* Individuals who have previously participated in a B. pertussis human challenge study\n* Individuals who have had a proven B. pertussis infection in the last 5 years\n* Individuals who have a history of never being vaccinated against B. pertussis\n* Current smokers defined as having had a cigarette\u002Fcigar in the last week (including vaping)\n* Use of systemic antibiotics within 30 days of or during the challenge\n* Any confirmed or suspected immunosuppressive or immune-deficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed)\n* Use of immunoglobulins or blood products within 3 months prior to enrolment\n* History of allergic disease or reactions likely to be exacerbated by any component of the inoculum\n* Contraindications to the use of azithromycin or macrolides\n* Pregnancy, lactation or intention to become pregnant during the study\n* Any clinically significant abnormal finding on biochemistry, haematology, toxicology or serological blood tests, urinalysis (see The following reference ranges are provided for the purpose of guidance only. Results that fall outside of these ranges may not be of clinical significance but should be considered on an individual basis.) or clinical examination - in the event of abnormal test results, confirmatory repeat tests will be requested\n* Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data, for example recent surgery to the nasopharynx\n\nExclusion criteria - Contact volunteers\n\n* Individuals living in the same households as:\n\n  1. unimmunised or partially immunised children and infants aged \\\u003C 1 year\n  2. pregnant women\n  3. immunosuppressed individuals\n  4. frail individuals\n  5. healthcare workers working with vulnerable individuals as above\n* Individuals who have inviolable commitments within the study period (from day 0 to week 6 + 2 days) to be in close contact with:\n\n  1. unimmunised or partially immunised children and infants aged \\\u003C 1 year\n  2. pregnant women \\>32 weeks who have not received pertussis vaccination at least a week prior to contact\n  3. immunosuppressed individuals\n  4. frail individuals\n* Individuals who have been involved in other clinical trials involving receipt of an investigational product over the last 12 weeks or if there is planned use of an investigational product during the study period\n* Individuals who have previously participated in a B. pertussis human challenge study\n* Individuals who have a history of never being vaccinated against B. pertussis\n* Any confirmed or suspected immunosuppressive or immune-deficient state, including HIV infection; malignancy, asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed)\n* Contraindications to the use of azithromycin or macrolides\n* Any clinically significant abnormal finding on clinical examination\n* Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data\n* Pregnancy, lactation or intention to become pregnant during the study","55 Years",{"count":121,"type":21},72,[63],"Primary objective- To assess the safety of nasal inoculation of healthy volunteers with B. pertussis with antibiotic therapy given to eradicate colonisation at 6 weeks after inoculation or at symptom onset, whichever occurs first\n\nSecondary objectives - To measure the rate of natural clearance of carriage of B. pertussis following nasal inoculation\n\n* To assess the kinetics of B. pertussis colonisation density following nasal inoculation\n* To describe the microevolution of B. pertussis and adaptation of the resident microbiome during B. pertussis carriage\n* To measure B. pertussis-specific antibody and cellular immunological responses in healthy volunteers during colonisation with B. pertussis - To identify biomarkers that correlate with natural clearance of B. pertussis carriage after induced B. pertussis colonisation\n* To detect transmission of B. pertussis to bedroom contacts of inoculated volunteers during prolonged asymptomatic colonisation",[27],"2026-05-14",{"date":127,"type":42},"2026-05-18",{"date":129,"type":42},"2022-12-06",{"date":131,"type":21},"2026-12-01",{"name":133,"class":81},"University of Southampton",{"id":135,"slug":4,"hasResults":10,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100617109","NCT07314346","Drug-drug Interaction Study of Bemnifosbuvir\u002FRuzasvir (BEM\u002FRZR) and Buprenorphine\u002FNaloxone or Methadone","A Phase 1, Open-Label, Two-Part, Single-Sequence Study to Evaluate the Effect of Multiple Oral Doses of BEM\u002FRZR FDC on the Pharmacokinetics of Buprenorphine\u002FNaloxone or Methadone in Participants on Stable Maintenance Therapy for Opiate Withdrawal","Inclusion Criteria:\n\n* Must agree to use acceptable contraceptive methods through at least 90 days after the last dose of study drug.\n* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg\u002F m2.\n* Willing to comply with the study requirements and to provide written informed consent.\n\nExclusion Criteria:\n\n* Infected with hepatitis B virus, hepatitis C virus, HIV.\n* Abuse of alcohol or drugs.\n* Use of other investigational drugs within 28 days prior to Day -5.\n* Concomitant use of prescription medications, or systemic over-the-counter medications (apart from methadone or buprenorphine\u002Fnaloxone as assigned maintenance therapy).\n* Other clinically significant medical conditions or laboratory abnormalities.",{"count":141,"type":21},32,[24],"Drug-drug interaction study between Bemnifosbuvir\u002FRuzasvir (BEM\u002FRZR) and Buprenorphine\u002FNaloxone or Methadone",[27],"2026-04-08",{"date":147,"type":42},"2026-04-13",{"date":149,"type":42},"2025-01-07",{"date":151,"type":21},"2026-06",{"name":153,"class":49},"Atea Pharmaceuticals, Inc.",3,{"id":156,"slug":4,"hasResults":10,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100586126","NCT06911320","Study of Bemnifosbuvir\u002FRuzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function","A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of Bemnifosbuvir and Ruzasvir Administered as a Fixed-Dose Combination in Adult Participants With Severe Renal or Hepatic Impairment in Comparison to Healthy Participants","Inclusion Criteria:\n\n* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug\n* Females must have a negative pregnancy test at Screening and prior to dosing\n* BMI of 18.5 to 43.0 kg\u002Fm2\n* Willing to comply with the study requirements and to provide written informed consent\n\nRenal Impaired Subjects (Group 1):\n\n* Considered stable in the judgement of an Investigator\n* Presence of severe renal impairment or kidney failure (as defined by eGFR\\\u003C 30 mL\u002F min)\n\nHepatic Impaired Subjects (Group 2):\n\n* Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator\n* Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).\n\nSubjects with Normal Hepatic and Renal Function (Group 3):\n\n* Medically healthy, in the opinion of an Investigator\n* Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Infected with hepatitis B virus, hepatitis C virus or HIV\n* Abuse of alcohol or drugs\n* Use of other investigational drugs within 28 days of dosing\n* Other clinically significant medical conditions or laboratory abnormalities\n\nRenal and Hepatic Impaired Subjects (Group 1 and 2):\n\n* Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c \\> 10%\n* Undergoing any method of dialysis\n* Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan\n\nRenal Impaired Subjects (Group 1):\n\n* History of renal transplant\n* Concurrent use of medications known to affect the elimination of serum creatinine\n\nHepatic Impaired Subjects (Group 2):\n\n* History of liver transplant\n* Evidence of hepatic carcinoma presence at Screening","80 Years",{"count":163,"type":21},28,[24],"To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir\u002FRuzasvir After a Single Dose",[27,167,168],"Hepatic Impairment","Renal Impairment",{"date":147,"type":42},{"date":171,"type":42},"2025-04-09",{"date":173,"type":21},"2026-05",{"name":153,"class":49},2,{"id":177,"slug":4,"hasResults":10,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":50},"100579520","NCT06825364","Near-InfraRed Spectroscopy of Auricular Stimulation","Neural Responses to Tactile Auricular Stimulation Measured by Functional Near-infrared Spectroscopy in Pain-free Volunteers","NIRAS","Inclusion Criteria:\n\nAge of at least 18 years\n\nExclusion Criteria:\n\n1. frequent or chronic pain requiring the use of pain-relieving medications more than twice per week, on average, in the last 3 months,\n2. history or symptoms of neuropathy,\n3. active lesions or skin disruptions to either ear,\n4. recent (\\\u003C 3 mo) illicit drug use,\n5. history of substance misuse\u002Fabuse,\n6. current or recent (\\\u003C1 month) opioid or marijuana use, and\n7. current regular use of psychoactive prescription medications",{"count":184,"type":21},80,[63],"This is a single-visit non-invasive study of healthy volunteer subjects. Brain activity will be measured with infra-red light sensors attached to a cap worn on the head, while both ears are gently stimulated with plastic filaments.",[188,27],"Healthy Male and Female Subjects",[190,191],"auricular stimulation","functional near infrared spectroscopy","2026-02-13",{"date":194,"type":42},"2026-02-18",{"date":196,"type":42},"2025-08-12",{"date":198,"type":21},"2028-02-01",{"name":200,"class":81},"University of Pittsburgh",{"id":202,"slug":4,"hasResults":10,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":213,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":175},"100591692","NCT06983730","The Kidney's Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response","Development of a Clinical Experimental Heat Stress Protocol and Exploration of the Effect of Niacinamide on Physiologic, Metabolic, and Biochemical Responses to Heat Stress","Inclusion Criteria:\n\n* Healthy volunteer\n* Any race\n* Estimated glomerular filtration rate greater than 90 ml\u002Fmin\u002F1.73m2\n* Urine albumin\u002Fcreatinine ratio less than 30mg\u002Fg\n* Nonsmoker\n* No regular dietary supplements, particularly vitamin B3\n* Physically fit, defined as having a VO2 max of between 35 and 60mL\u002Fkg\u002Fmin\n\nExclusion Criteria:\n\n* Medical condition preventing safe participation in exercise during heat\n* Allergy to Vitamin B3\n* Severe food allergies or dietary restrictions that would preclude eating the planned study diet without major modifications",{"count":163,"type":21},[92],"The goal of this clinical trial is to learn about the processes occurring in the kidneys while under heat stress in healthy volunteers. The main questions it aims to answer are:\n\n* How do the chemicals produced by the body change under conditions of higher versus lower heat stress?\n* What role does a specific area of the body's metabolism, known as NAD+ metabolism, play in the body's response to heat stress, and can this response be modified by taking vitamin B3?",[211,27,212],"Heat Strain","Kidney Dysfunction",[214,215,216,217],"NAD+","Niacinamide","Vitamin B3","Experimental heat strain","2026-02-03",{"date":220,"type":42},"2026-02-05",{"date":222,"type":42},"2026-01-26",{"date":224,"type":21},"2028-06",{"name":226,"class":81},"Beth Israel Deaconess Medical Center",{"id":228,"slug":4,"hasResults":10,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":50},"100595558","NCT07034014","An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices","A Healthy Volunteer, Single Center, Exploratory Investigation to Evaluate Wearing Properties of Three Different Non-sterile Silicone Self-adhesive Investigational Devices","Inclusion Criteria:\n\n* Participants who are capable and willing to comply with protocol visits, assessments, and instructions.\n* Participants must be in general good health with healthy and intact skin in the test area (as determined by the investigator based on medical history and examination of the application sites).\n* Minimal hairiness at the back (location of the application sites).\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Known allergy\u002Fhypersensitivity to the dressing or its components.\n* Participants with any features at the application sites will be in contact with the adhesive surface of the dressing, and could influence the investigation.\n* Participants not willing to avoid contact of the application sites with water in the morning prior to dressing application and throughout the entire course of the study.\n* Participants not willing to avoid applying any detergents to the application sites in the morning prior to dressing application and throughout the entire course of the study.\n* Participants not willing to avoid the use of leave on cosmetics such as creams\u002Flotions and sunscreens at the application sites 3 days leading up to dressing application and throughout the entire course of the study.\n* Participants not willing to refrain from activities which may directly affect the dressings, application sites or assessments in the morning prior to dressing application and throughout the entire course of the study.\n* Participants whose back is not large enough to accommodate all 12 application sites\n* Any severe systemic disease that may interfere with the performance, evaluation, and outcome of the investigation as judged by the investigator.\n* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and\u002For hormonal treatment within the last 2 years.\n* Active skin disease at the application sites .\n* Any topical medication at the application sites within the last 24 hours prior to the start of the test and\u002For throughout the entire course of the investigation.\n* Pain relief medication on assessment visits . If it is essential for the participant to take pain relief medication on the days mentioned above for any unforeseen reasons, the participant is allowed to use pain relief medication but has to report this to the study center in order to be documented as protocol deviation.\n* Pregnancy or lactation.\n* Drug addicts, alcoholics.\n* AIDS, HIV-positive or infectious hepatitis.\n* Individuals who are inmates in psychiatric wards, prison or state institutions, or any individuals otherwise regarded as vulnerable (as per ISO 14155 Section 3.55).\n* Participation in another investigative drug or device study currently or within the last 30 days.\n* Current participation in a cosmetic study.\n* Employees of the investigation sites directly involved in this clinical investigation.\n* Employees of the sponsor's company.\n* Employees of a competitor company. The participant should not work for any company which produces dressings.\n* The participant is considered by the Investigator to be unsuitable to participate in the investigation for any other reason",{"count":234,"type":21},35,[63],"This clinical investigation will assess the self-adhesive properties of two investigational devices compared to a test specimen reference.",[27],"2025-06-13",{"date":240,"type":42},"2025-06-24",{"date":242,"type":42},"2025-06-05",{"date":244,"type":21},"2025-08",{"name":246,"class":49},"Molnlycke Health Care AB",{"id":248,"slug":4,"hasResults":10,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":259,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":50},"100592690","NCT06996704","A Clinical Study of AK0610","A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of AK0610 in Healthy Chinese Adults.","Inclusion Criteria:\n\n1. Participants aged 18 - 50 (both males and females)\n2. Males weighing ≥50 kg, females weighing ≥45 kg, and BMI 18-28 kg\u002Fm2.\n3. Assessed by the investigator to be in good health with no clinically significant abnormalities.\n4. Use of highly effective contraception within 1 year of administration.\n5. Voluntary participation in clinical research and signing of written informed consent.\n\nExclusion Criteria:\n\n1. Clinically significant cardiovascular, respiratory, hepatic, renal, hematologic (e.g., bleeding disorders), gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric system disorders, or any other condition that, in the opinion of the Investigator, may jeopardize subject safety or validity of the study results, or that may result in the inability of the subject to complete the study in accordance with the protocol.\n2. Active malignancy and\u002For a history of malignancy (except for basal cell carcinoma of the skin that has been treated without evidence of recurrence)\n3. History of congenital or acquired immunodeficiency.\n4. Acute illness, such as fever, infectious disease, diarrhea, etc., occurring within 1 week prior to the subject's first dose.\n5. Major surgery within 3 months prior to screening or major surgery planned within 1 year of study drug administration.\n6. Hypersensitivity to the active ingredient of AK0610 or any excipients.\n7. Previous history of allergy to biologics or history of severe allergic reaction (e.g. hypotension, dyspnea, severe angioedema) to any drug.\n8. Human immunodeficiency virus (HIV) antibody positive; hepatitis C virus (HCV) antibody positive or hepatitis B surface antigen (HBsAg) positive; syphilis spirochete antibody positive.\n9. Systolic blood pressure ≥140 mmHg or \\\u003C90 mmHg or diastolic blood pressure ≥90 mmHg or \\\u003C60 mmHg, and pulse \\\u003C55 or \\>100 beats\u002Fmin.\n10. ECG suggestive of prolonged QTcF (≥450 ms in both women and men). \\[QTcF= QT\u002F(RR\\^0.33)\\]\n11. Use of any prescription, over-the-counter, herbal, proprietary, or health care product (other than birth control pills) within 14 days prior to study drug administration.\n12. Have received treatment with immune globulin or other blood products within 6 months prior to study drug administration\n13. Have received treatment with monoclonal antibodies or other biological products within 6 months prior to administration of study drug.\n14. Have received a live attenuated vaccination within 1 month prior to study drug administration, has received another vaccination within 14 days, or is scheduled to receive a vaccination within 1 year of study drug administration.\n15. Received any other investigational drug therapy within 3 months (or 5 half-lives, whichever is longer) prior to study drug administration, or plans to participate in another study within 1 year of study drug administration.\n16. Participating or have participated in another interventional clinical study of a monoclonal antibody or vaccine against RSV.","50 Years",{"count":255,"type":21},136,[24],"The study consists of two parts: dose escalation and expansion. It includes five cohorts in the dose-escalation phase and two expansion cohorts based on pharmacokinetic data.",[27],[260],"Phase 1 study of AK0610","2025-05-21",{"date":263,"type":42},"2025-05-30",{"date":265,"type":42},"2024-02-29",{"date":267,"type":21},"2025-09",{"name":269,"class":49},"Shanghai Ark Biopharmaceutical Co., Ltd.",{"id":271,"slug":4,"hasResults":10,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":285,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":50},"100592051","NCT06988397","Stomach Processing and Emptying Evaluation With Diet and Ultrasound","Food Type and Physical Activity Influence on Gastric Emptying Time Assessed by Ultrasound in Healthy Volunteers","SPEED-US","Inclusion Criteria:\n\n* Age between 18 and 40 years\n* Ability and willingness to provide written informed consent\n* Agreement to comply with study procedures, including pre-study dietary restrictions\n* No history of gastrointestinal disease\n* No recent abdominal surgery\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Allergy or intolerance to any of the foods used in the study meals\n* Medical conditions known to delay gastric emptying, including:\n* Obesity (BMI \\> 30 kg\u002Fm²)\n* Diabetes mellitus\n* Gastroesophageal reflux disease (GERD)\n* Hiatal hernia\n* Bowel obstruction\n* Tube feeding\n* Active gastrointestinal disease\n* History of gastrointestinal surgery\n* Current pregnancy or breastfeeding\n* Use of medications affecting gastric motility (e.g., opioids, anticholinergics, GLP-1 receptor agonists)\n* Neuromuscular disorders impairing ability to remain in supine position for 6 hours or to walk for 30 minutes","40 Years",{"count":279,"type":21},60,[63],"Gastric content is a key risk factor for aspiration during anesthesia. Although standard fasting times are recommended, various factors-including GLP-1 receptor agonists,-can delay gastric emptying. Gastric ultrasound enables real-time, non-invasive assessment of gastric volume and can help tailor perioperative management. The aim of this study explores the effects of different meal types and physical activity on gastric emptying in healthy individuals.",[283,284,27],"Gastric Emptying","Preoperative Risk Assessment",[286,287,288,289],"Gastric emptying","Gastric volume","Ultrasound","Gastric POCUS","2025-05-15",{"date":292,"type":42},"2025-05-23",{"date":294,"type":21},"2025-06-01",{"date":296,"type":21},"2026-06-01",{"name":298,"class":81},"Medical University of Warsaw",{"id":300,"slug":4,"hasResults":10,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":15,"sex":16,"minAge":119,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":311,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":50},"100588762","NCT06945614","Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation","A Proof-of-Concept, Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation in Healthy Human Subjects","Inclusion Criteria:\n\nStudy subjects must meet the following eligibility criteria to participate in the study.\n\n1. Male or female, aged 55-75 years.\n2. Good general health with no disease likely to interfere with the study assessments.\n3. Baseline vital signs within the following ranges:\n\n   1. resting heart rate 60 to 90 BPM with Normal Sinus Rhythm\n   2. respiratory rate less than 14\n   3. resting diastolic blood pressure greater than 60 mm Hg and less than 90 mm Hg and resting systolic blood pressure less than 140 mm Hg and more than 110 mm Hg\n   4. Peripheral blood oxygen saturation \\>95%\n4. Immunizations fully up to date at Screening, according to the assessment of their primary care physician.\n5. Negative urine pregnancy test within 7 days prior to the first dose of investigational product for women of childbearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses any time in the preceding 24 consecutive months). Sexually active women of childbearing potential and male subjects must agree to use two effective contraceptive methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 90 days after the completion of study treatment. Contraceptive methods will be documented with other concomitant medications.\n6. Willingness to comply with all study requirements.\n7. Adequate cognitive function to understand and sign the IRB-approved ICF before any protocol-specific screening procedures are performed.\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria at Screening will be excluded from the study:\n\n1. Body mass index \\>30.\n2. Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening visit.\n3. Active SARS-CoV-2 (COVID-19) disease.\n4. A female who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study.\n\n   1. Females of childbearing potential will undergo a pregnancy test at Screening and be excluded from the study if positive.\n   2. A urine pregnancy test will also be performed on the morning of the dosing day.\n5. History of a clinically significant acute or chronic disease that is not stable and medically managed in the judgment of the study physician.\n6. History of bradycardia or other cardiovascular dysrhythmias or who are receiving beta blockers.\n7. Cardiopulmonary disease, including pulmonary fibrosis, COPD, altered pulmonary function, lung injury, pulmonary hypertension, obstructive sleep apnea requiring CPAP.\n8. Bowel obstruction, pneumocephalus, or other diseases with the potential for an air pocket and expansion following xenon administration.\n9. Any medical condition or receiving any medications that predispose to delayed gastric emptying.\n10. Known difficult airway, or potential for a difficult airway based on a thorough airway exam by an anesthesiologist.\n11. Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, thyroid disease, or type 1 diabetes.\n12. Use of corticosteroids within the past month prior to the first treatment.\n13. History of cancer in the past 5 years, with the exception of successfully treated basal cell carcinoma.\n14. Any other clinically significant medical condition or illness as determined by medical history, clinical laboratory results, or other screening safety tests that, in the judgment of the Investigator, would interfere with participation in this study.\n15. History of alcohol or substance abuse or dependence within the past 2 years.\n16. Clinically significant abnormalities in screening laboratories.","75 Years",{"count":307,"type":21},16,[24],"The goal of this clinical study is to evaluate safety of Xenon gas inhalation in healthy volunteers. This first phase safety clinical study is part of evaluation of the xenon gas inhalation as a therapy for neurodegenerative diseases, such as Alzheimer's disease.\n\nThe investigators will administer xenon gas in low concentration to people via anesthetic machine, observe participants for sedation and any unexpected side effects, collect blood at each visit and measure the vital signs. There are four treatment groups in the study, which correspond with the duration of xenon gas treatment. Individual participation will last approximately 14 days over five visits: screening visit accompanied by the electrocardiogram, blood, and urine test; treatment visit for xenon gas inhalation treatment; and three follow up visits.",[27],[312,313,314,315,316],"Xenon gas","inhalation","Alzheimer's disease","neurodegenerative","Healthy volunteer","2025-04-18",{"date":319,"type":42},"2025-04-25",{"date":321,"type":42},"2025-04-16",{"date":323,"type":21},"2025-12-31",{"name":325,"class":49},"General Biophysics LLC",{"id":327,"slug":4,"hasResults":10,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":50},"100579912","NCT06830460","Measurement of the Optic Nerve Diameter in Different Healthcare Operators","Efficacy of a Theoretical-practical Course for the Ultrasound Measurement of the Optic Nerve Diameter in Different Healthcare Operators","Inclusion Criteria:\n\n* medical student, or nurse student, or residents in anesthesia or nurse with at least 3 years of Intensive care unit experience\n\nExclusion Criteria:\n\n* previous skills on ONSD measurements",{"count":333,"type":21},40,[63],"The study evaluates the effectiveness of a theoretical-practical training course for the ultrasound measurement of the optic nerve sheath diameter (ONSD), a non-invasive method used to estimate intracranial pressure (ICP). The optic nerve sheath is continuous with the subarachnoid space, which contains cerebrospinal fluid (CSF). An increase in ICP leads to an increase in CSF within the sheath, enlarging its diameter. ONSD measurement is typically performed by placing an ultrasound probe on the closed eyelid, allowing visualization of the optic nerve behind the eyeball.\n\nWhile the correlation between ONSD enlargement and elevated ICP is well-documented, there is variability in diagnostic cut-off values due to differences in measurement techniques, equipment, and operator experience. Previous studies have shown that even novice operators can achieve clinically acceptable accuracy after brief training.\n\nThis study aims to assess whether medical students, nursing students, anesthesiology and intensive care residents, and intensive care nurses can learn to perform reliable ONSD measurements after a short training session.\n\nMethodology:\n\nThe study will involve 40 participants unfamiliar with ONSD measurement: 10 medical students, 10 nursing students, 10 anesthesiology and intensive care residents, and 10 experienced intensive care nurses. The training will consist of a four-hour session, including a 30-minute lecture on ocular anatomy and ultrasound techniques, a real-time demonstration, and supervised hands-on practice with at least 20 measurements.\n\nParticipants must pass a multiple-choice test with at least 70% correct answers to proceed to practical verification, where they will measure ONSD in five healthy volunteers. These measurements will be compared with those taken by an expert tutor.\n\nMeasurement Technique:\n\nThe ultrasound technique follows expert consensus guidelines, using a linear probe with a minimum frequency of 7.5 MHz. Volunteers will be positioned semi-seated at a 45° head elevation with closed eyelids. The ONSD measurement will be taken 3 mm behind the retina on the right eye. Care will be taken to avoid pressure on the eyeball, and safety parameters will be monitored to ensure compliance with FDA guidelines.\n\nThe study aims to demonstrate that various healthcare professionals can achieve accurate and reliable ONSD measurements with proper training, enhancing the utility of this technique in diverse clinical settings.",[337,27],"Healthy Volunteer",[339,340],"optic nerve sheath diameter","theoretical-practical course","2025-02-11",{"date":343,"type":42},"2025-02-17",{"date":345,"type":21},"2025-03-01",{"date":347,"type":21},"2025-03-31",{"name":349,"class":81},"University Magna Graecia",{"id":351,"slug":4,"hasResults":10,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":15,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":377},"100575063","NCT06767410","A Multi-domain Intervention for Healthy Aging","A Multi-domain Intervention to Constrast Cognitive Decline in Healthy Aging","MultiMusic","Inclusion Criteria:\n\n* Age ≥ 65\n* Living independently\n\nExclusion Criteria:\n\n* Musical expertise\n* Severe cognitive or functional impairment",{"count":358,"type":21},100,[63],"This study aims to investigate the long-term impact of a non-pharmacological intervention including several activities (e.g., physical activity, choir, learning programs, horticulture, etc.) to prevent cognitive impairment in community-dwelling elderly individuals with aspects of frailty. The main questions it aims to answer are:\n\n* Does engaging in multiple activities, including music, slow the degeneration of perceptual and cognitive functions?\n* Is it possible to foster beneficial brain changes even during aging?\n* Can regularly attending social contexts reduce the risk of loneliness and provide fulfillment in later life? Researchers will compare participants involved in the multidomain intervention, including music, to another active group carrying out several activities but without music, and to a passive control group.\n\nParticipants will:\n\n* Participate in the programs for 9 months;\n* Be tested three times (before and after the intervention, and at a 6-month follow-up);\n* Keep a weekly diary of the actual time spent in their activities.",[27],[363,364,365,366,367],"BDNF","aging","multidomain intervention","music training","neuroplasticity","2025-01-05",{"date":370,"type":42},"2025-01-09",{"date":372,"type":21},"2025-10-01",{"date":374,"type":21},"2027-12",{"name":376,"class":81},"University of Bari",4,{"id":379,"slug":4,"hasResults":10,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":4},"100570555","NCT06708767","Safety Study of CZ10 in Healthy Volunteers","Randomized Double Blind Phase 1 Safety Study of CZ10 in Healthy Volunteers","Inclusion Criteria:\n\n* Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures\n* Subject is between the ages of 18 to 85 years old, inclusive\n* Has good venous access as determined by the Investigator at screening\n* Weighs up to 450 lbs\n\nExclusion Criteria:\n\n* Is pregnant (as determined by a urine pregnancy test at the time of consent)\n* Has significant cardiovascular, respiratory, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and\u002For pose safety concerns;\n* Has evidence of moderate to severe renal insufficiency or renal failure (defined as an estimated glomerular filtration rate \\\u003C60 ml\u002Fminute)\n* Has an allergy to iodinated or other medical intravenous contrast material\n* Weighs more than 450 pounds\n* Is breastfeeding\n* Is a woman of childbearing age who is not using double protection birth control","85 Years",{"count":386,"type":21},24,[24],"A randomized, double-blind, placebo-controlled, parallel group, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and initial effectiveness of a novel intravenous CT contrast material (CZ10).\n\nThis first-in-human clinical phase 1 trial will test the safety of escalating doses of CZ10 that has shown high safety and efficacy as a intravenous contrast agent in preclinical trials.\n\nThe subjects for this study will be healthy adult volunteers, including obese but otherwise healthy subjects up to 450 lbs or the maximum allowable weight of the CT scanner, whichever is lighter. Subjects will be recruited and randomly assigned to cohort and test article.\n\nA total of 24 subjects will be evaluated with 18 subjects randomized to receive active drug and 6 subjects randomized to receive placebo control in a double blind manner. A total of three cohorts of 8 subjects will be enrolled. The first cohort subjects will receive a low dose, then if less than 2 subjects show severe adverse events, the second cohort will receive the expected clinical dose, then if less than 2 subjects show severe adverse events, the last cohort will receive a high dose of the intravenous test article. For each cohort, six subjects will be randomized to receive CZ10 and two to placebo. To increase subject safety, two initial subjects from each cohort will be randomized one to receive CZ10 and the other to receive placebo. If there are no serious adverse events through 3 days post dosing, then the remainder of the cohort will be enrolled.\n\nSubjects will be screened and enrolled up to 30 days prior to the day of test article dosing. Inclusion criteria are adult subjects willing to consent for the trial. Exclusion criteria are persons: (a) who are pregnant (as determined by a urine pregnancy test at the time of consent); (b) who have significant cardiovascular, respiratory, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and\u002For pose safety concerns; (c) Have evidence of moderate to severe renal insufficiency or renal failure (defined as an estimated glomerular filtration rate \\\u003C60 ml\u002Fminute); (d) who have an allergy to iodinated CT or other medical intravenous contrast material; (e) who are more than 450 pounds which would result in inability to be scanned on CT; or (f) have poor venous access such that an 18g venous cannula cannot be placed into the antecubital or other large superficial arm vein. Exclusion criteria also include women who are breastfeeding and women of childbearing age who are not using double protection birth control.\n\nSafety assessments will include monitoring of adverse events, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead ECGs, subject reporting of symptoms, and physical examination findings. A physical examination will be performed at screening and on Day 2 and Day 7. A resting 12-lead ECG will be performed at screening, pre-dose and on Day 1 at 4 hours, Day 2, and Day 7. Vitals signs will be assessed at screening, at admission to the clinical research unit the day of dosing, then at 2, 4, and 7 hours after dosing, and on Day 2 and Day 7. Clinical laboratory tests (chemistry and hematology) will be performed at screening, pre-dose, at 7 hours after start of oral dosing, and Day 2 and 7 after dosing. A phone call interview to assess for symptoms will occur on day 15. In particular subjects will be monitored for possible allergic reaction, contrast material extravasation, and possible renal injury. If any adverse events are seen, the subject will be return to the clinical research unit for further assessment and possible treatment.\n\nTentatively, the doses of CZ10 are expected to be 400, 800, and 1200 mg \u002F kg of CZ10 but final doses will depend on preclinical and manufacturing data. The dose of test article will likely be limited by volume of material that can be bolus injected (maximum feasible dose). The placebo will be given at the same dose volume as the CZ10 drug product.\n\nAt the conclusion of the study, the necessary safety data will be available to decide on whether and how to proceed with clinical phase 2 studies on patients with suspected or known vascular disease.",[27],[391,392,393,394,395],"Adverse event","Serious adverse event","safety","intravenous contrast agent","CZ10","2024-11-26",{"date":398,"type":42},"2024-11-29",{"date":400,"type":21},"2050-01",{"date":402,"type":21},"2054-01",{"name":404,"class":49},"Nextrast, Inc.",""]