[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615444":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"CM383 subcutaneous injection group 1","EXPERIMENTAL",null,[13],"Biological: CM383",{"label":15,"type":10,"description":11,"interventionNames":16},"CM383 subcutaneous injection group 2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"CM383 intravenous infusion group",[13],[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"BIOLOGICAL","CM383","CM383 subcutaneous injection, once.",[9,15],{"type":22,"name":23,"description":27,"armGroupLabels":28,"otherNames":11},"CM383 intravenous infusion, once.",[18],[30],{"name":31,"affiliation":32,"role":33},"Bo Jiang","The Second Affiliated Hospital Zhejiang University School of Medcine","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[41],{"facility":32,"status":42,"city":43,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Hangzhou","China","CN",{"type":47,"coordinates":48},"Point",[49,50],120.16142,30.29365,{"lat":50,"lon":49},[53],{"name":31,"role":37,"phone":54,"phoneExt":11,"email":55},"0571-87783508","jiangbo@zju.edu.cn",{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100615444","phase-1-study-of-cm383-in-healthy-subjects-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":70,"type":71},30,"ESTIMATED","INTERVENTIONAL",[74],"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.",[77],"Healthy","2026-01-22",{"date":80,"type":81},"2026-01-23","ACTUAL",{"date":83,"type":71},"2026-01",{"date":85,"type":71},"2026-07",{"name":5,"class":6},1]