[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498806":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"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,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52],{"name":29,"role":35,"phone":53,"phoneExt":26,"email":54},"13161753111","jichenglv75@gmail.com",{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100498806","phase-2-clinical-study-of-cm338-in-the-treatment-of-immunoglobulin-a-nephropathy-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":68,"type":69},70,"ESTIMATED","INTERVENTIONAL",[72],"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.",[75],"IgA Nephropathy","2024-10-14",{"date":78,"type":79},"2024-10-15","ACTUAL",{"date":81,"type":79},"2023-05-08",{"date":83,"type":69},"2027-06-30",{"name":5,"class":6},1]