[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592690":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":44,"centralContacts":49,"locations":55,"responsibleParty":72,"collaborators":44,"id":74,"slug":44,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":44,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":44,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":58,"whyStopped":44,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Shanghai Ark Biopharmaceutical Co., Ltd.","INDUSTRY",[8,15,19,23,27,31,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 ml","EXPERIMENTAL","AK0610 100 mg or Placebo 1 ml，Intramuscular injection，once on Day 1.",[13,14],"Drug: AK0610 Injection solution","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 ml","AK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 ml","AK0610 300 mg or Placebo 3 ml，Intravenous injection，once on Day 1.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 ml","AK0610 1000 mg or Placebo 10 ml，Intravenous injection，once on Day 1.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 ml","AK0610 3000 mg or Placebo 30 ml，Intravenous injection，once on Day 1.",[13,14],{"label":32,"type":10,"description":17,"interventionNames":33},"Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 ml",[13,14],{"label":35,"type":10,"description":36,"interventionNames":37},"Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 ml","AK0610 600mg or Placebo 6ml，Intramuscular injection，once on Day 1.",[13,14],[39,45],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","AK0610 Injection solution","Active Substance: AK0610 Pharmaceutical Form: Injection solution Route of Administration: Intramuscular injection or intravenous injection.",[9,16,20,24,28,32,35],null,{"type":40,"name":46,"description":47,"armGroupLabels":48,"otherNames":44},"Placebo","Active Substance: Placebo Pharmaceutical Form: Injection Route of Administration: Intramuscular injection or intravenous injection",[9,16,20,24,28,32,35],[50],{"name":51,"role":52,"phone":53,"phoneExt":44,"email":54},"Nina Shen","CONTACT","02150681677","nina.shen@arkbiosciences.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":44,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital ）","RECRUITING","Jinan","Shandong","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.99722,36.66833,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":44,"phoneExt":44,"email":44},"Wei Zhao",{"type":73,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100592690",false,"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.",true,"ALL","18 Years","50 Years",{"count":85,"type":86},136,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","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.",[92],"Healthy Volunteer Study",[94],"Phase 1 study of AK0610","2025-05-21",{"date":97,"type":98},"2025-05-30","ACTUAL",{"date":100,"type":98},"2024-02-29",{"date":102,"type":86},"2025-09",{"name":5,"class":6},1]