[{"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":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100531008","phase-2-a-trial-of-intravenous-hrs9432-in-the-treatment-of-subjects-with-candidemia-andor-invasive-candidiasis-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":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and\u002For invasive candidiasis",[26],"Patients With Candidemia and\u002For Invasive Candidiasis","RECRUITING","2024-11-15",{"date":30,"type":31},"2024-11-18","ACTUAL",{"date":33,"type":31},"2024-04-27",{"date":35,"type":20},"2026-06",{"name":37,"class":38},"Fujian Shengdi Pharmaceutical Co., Ltd.","INDUSTRY"]