[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612075":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":49,"collaborators":25,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":25,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Climb Bio, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CLYM116","EXPERIMENTAL","Subcutaneous (SC) injection of CLYM116",[13],"Drug: CLYM116",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Subcutaneous (SC) injection of placebo",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","CLYM116 to be administered by SC injection",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo solution to be administered at a matching volume by SC injection",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Climb Bio Study Director","CONTACT","+1 866 857 2596","clinicaltrials@climbbio.com",[36],{"facility":37,"status":38,"city":39,"state":25,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"Nucleus Network Brisbane","RECRUITING","Brisbane","4006","Australia","AU",{"type":44,"coordinates":45},"Point",[46,47],153.02809,-27.46794,{"lat":47,"lon":46},{"type":50,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100612075","phase-1-a-phase-1-study-of-clym116-in-normal-healthy-volunteers-100612075",false,"NCT07248865","A Phase 1 Study of CLYM116 in Normal Healthy Volunteers","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose (SAD) and Multiple-Ascending-Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injection(s) of CLYM116 in Normal Healthy Volunteers","Inclusion Criteria:\n\n* Healthy adult males and females aged 18-60 years, inclusive\n* Body mass index (BMI) between 18 and 32 kg\u002Fm² and weight between 45 and 110 kg\n* Clinically normal medical history, physical exam, ECG, and laboratory results (or abnormalities deemed not clinically significant)\n* Willing and able to comply with study procedures and provide informed consent\n* Women of childbearing potential must use highly effective contraception and have negative pregnancy tests\n* Men must use contraception and refrain from sperm donation for 4 months post-dose\n* Completion of COVID-19 vaccination according to local guidelines, as well as influenza vaccination (within 12 months)\n\nExclusion Criteria:\n\n* Prior treatment with investigational drugs within 30 days or 5 half-lives\n* Previous or current hypogammaglobulinemia\n* Current presence of allergic reactions considered clinically significant\n* Positive tests for HIV, hepatitis B\u002FC, syphilis, or tuberculosis\n* Tobacco use (\\>2 cigarettes\u002Fday), alcohol abuse, or drug abuse\n* Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)",true,"ALL","18 Years","60 Years",{"count":63,"type":64},48,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.",[70],"Healthy Volunteers",[9,72,73,74,75,76,77],"APRIL","monoclonal antibody","healthy volunteers","Phase 1","IgA nephropathy","MIL116","2026-02-19",{"date":80,"type":81},"2026-02-20","ACTUAL",{"date":83,"type":81},"2025-12-02",{"date":85,"type":64},"2026-09",{"name":5,"class":6},1]