[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615444":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":32,"overallOfficials":41,"centralContacts":46,"locations":52,"responsibleParty":68,"collaborators":13,"id":70,"slug":13,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":13,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":13,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":13,"overallStatus":54,"whyStopped":13,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Pharmacokinetic characteristics of a single-dose administration of CM383 in healthy male subjects","Pharmacokinetic concentrations in serum and pharmacokinetic parameters: maximum concentration (Cmax).","Up to Day 85",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21,26,29],{"label":22,"type":23,"description":13,"interventionNames":24},"CM383 subcutaneous injection group 1","EXPERIMENTAL",[25],"Biological: CM383",{"label":27,"type":23,"description":13,"interventionNames":28},"CM383 subcutaneous injection group 2",[25],{"label":30,"type":23,"description":13,"interventionNames":31},"CM383 intravenous infusion group",[25],[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":13},"BIOLOGICAL","CM383","CM383 subcutaneous injection, once.",[22,27],{"type":34,"name":35,"description":39,"armGroupLabels":40,"otherNames":13},"CM383 intravenous infusion, once.",[30],[42],{"name":43,"affiliation":44,"role":45},"Bo Jiang","The Second Affiliated Hospital Zhejiang University School of Medcine","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":13,"email":51},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[53],{"facility":44,"status":54,"city":55,"state":13,"zip":13,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Hangzhou","China","CN",{"type":59,"coordinates":60},"Point",[61,62],120.16142,30.29365,{"lat":62,"lon":61},[65],{"name":43,"role":49,"phone":66,"phoneExt":13,"email":67},"0571-87783508","jiangbo@zju.edu.cn",{"type":69,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100615444",false,"NCT07292688","Study of CM383 in Healthy Subjects","A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CM383 Following Intravenous and Subcutaneous Administration in Healthy Adult Subjects","Inclusion Criteria:\n\n* Subjects age ≥ 18 years \\& ≤54 years.\n* Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.\n\nExclusion Criteria:\n\n* The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening.\n* Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing.\n* History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening.\n* Blood donation or any other form of blood loss exceeding 400 mL, or accepting blood transfusion within 12 weeks prior to screening.\n* Suspected allergy to Aβ-antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs.\n* Severe trauma or undergo major surgery within 6 months prior to screening, or planned surgery during the research period.",true,"MALE","18 Years","54 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","This study is a Phase I, single-center, randomized, open-label, parallel-controlled study, aimed at evaluating the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of a single dose of CM383 administered via intravenous infusion or subcutaneous injection in healthy male subjects.",[88],"Healthy","2026-01-22",{"date":91,"type":92},"2026-01-23","ACTUAL",{"date":94,"type":82},"2026-01",{"date":96,"type":82},"2026-07",{"name":5,"class":6},1]