[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531008":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":33,"responsibleParty":52,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Fujian Shengdi Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HRS9432","EXPERIMENTAL",null,[13],"Drug: HRS9432",{"label":15,"type":16,"description":11,"interventionNames":17},"Caspofungin Acetate for Injection","ACTIVE_COMPARATOR",[18],"Drug: Caspofungin Acetate for Injection",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Dosing frequency: intravenously once week",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Dosing frequency: D1 70mg，followed by 50mg intravenously once daily",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Xiaopeng Wang","CONTACT","+86-182-6038-7118","xiaopeng.wang@hengrui.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The First Affiliated Hospital Of University Of South China","RECRUITING","Hengyang","Hunan","421001","China","CN",{"type":43,"coordinates":44},"Point",[45,46],112.61888,26.88946,{"lat":46,"lon":45},[49],{"name":50,"role":51,"phone":11,"phoneExt":11,"email":11},"Feng Wen","PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":64,"type":65},40,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and\u002For invasive candidiasis",[71],"Patients With Candidemia and\u002For Invasive Candidiasis","2024-11-15",{"date":74,"type":75},"2024-11-18","ACTUAL",{"date":77,"type":75},"2024-04-27",{"date":79,"type":65},"2026-06",{"name":5,"class":6},1]