[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patients-with-candidemia-andor-invasive-candidiasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patients-with-candidemia-andor-invasive-candidiasis":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":5},"100531008",false,"NCT06194201","A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and\u002For Invasive Candidiasis","A Multi-centre, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase II Study to Evaluate the Efficacy and Safety of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and\u002For Invasive Candidiasis","Inclusion Criteria:\n\n1. Males or females ≥18 years；\n2. Established or clinical diagnosis of candidemia and\u002For IC ；\n3. Present of 1 or more systemic signs attribute to candidemia and\u002For IC 4 days prior to randomization;\n4. Women of childbearing potential or male subjects whose partner is a fertile female agree to use highly effective form of contraception from the time of signed ICF till 6 months after end of treatment；\n5. Able and willing to provide a written informed consent\n\nExclusion Criteria:\n\n1. Any of the following forms of IC: including osteomyelitis, endocarditis or myocarditis, meningitis, endophthalmitis, or any central nervous system infection, urinary tract infection or chronic disseminated candidiasis；\n2. Severe hepatic impairment in subjects with a history of chronic cirrhosis；\n3. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement;\n4. Laboratory abnormalities in baseline specimens obtained at screening;\n5. ECG with clinical significance and may cause obvious safety risk to the subjects at screening;\n6. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or IC for \\>48 hours;\n7. Vascular catheter or device that cannot be removed, or abscess that cannot be drained, and may be the source of candidemia or IC;\n8. A history of drug use, alcohol, or drug abuse within 1 year prior to randomization;\n9. Participated in, any other clinical study involving the administration of active investigational or experimental medication prior to the randomization, or 5 half-lives, whichever is longer, prior to Screening;\n10. Females who are in gestation or lactating period or planned pregnancy during the study\n11. Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etc echinocandins drugs;\n12. In the judgment of the Investigator, other reasons unsuitable for study.","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and\u002For invasive candidiasis",[25],"Patients With Candidemia and\u002For Invasive Candidiasis","RECRUITING","2024-11-15",{"date":29,"type":30},"2024-11-18","ACTUAL",{"date":32,"type":30},"2024-04-27",{"date":34,"type":19},"2026-06",{"name":36,"class":37},"Fujian Shengdi Pharmaceutical Co., Ltd.","INDUSTRY",""]