[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498806":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":54,"collaborators":26,"id":56,"slug":26,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","CM338 will be injected subcutaneously.",[13],"Biological: CM338",{"label":15,"type":10,"description":11,"interventionNames":16},"Group B",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Group C",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","CM338","CM338 injection",[9,15,18],null,[28],{"name":29,"affiliation":30,"role":31},"Jicheng Lv","Peking University First Hospital","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[39],{"facility":30,"status":40,"city":41,"state":42,"zip":26,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Beijing","Beijing Municipality","China",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":29,"role":35,"phone":52,"phoneExt":26,"email":53},"13161753111","jichenglv75@gmail.com",{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100498806",false,"NCT05775042","Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy","A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy","Inclusion Criteria:\n\n* Male or female aged 18-75.\n* Understand the nature of the study and sign the Informed Consent Form voluntarily.\n* Take effective contraception measures throughout the study period.\n\nExclusion Criteria:\n\n* Used other investigational drugs within 30 days before the first study administration.\n* With previous history of Human immunodeficiency virus(HIV) infection.\n* Treponema pallidum antibody positive in screening period.\n* May have active Mycobacterium tuberculosis infection.\n* Major surgery is planned during the study.\n* Other reasons the investigator believes that the subject is not suitable to participate in this study.","ALL","18 Years","75 Years",{"count":66,"type":67},70,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This study is a multicenter, randomized phase II clinical study to evaluate Efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of CM338 in subjects with Immunoglobulin A(IgA) nephropathy.",[73],"IgA Nephropathy","2024-10-14",{"date":76,"type":77},"2024-10-15","ACTUAL",{"date":79,"type":77},"2023-05-08",{"date":81,"type":67},"2027-06-30",{"name":5,"class":6},1]