[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602201":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":44,"interventions":81,"overallOfficials":34,"centralContacts":91,"locations":97,"responsibleParty":117,"collaborators":34,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":34,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":34,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":34,"overallStatus":100,"whyStopped":34,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"Fortvita Biologics (USA)Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":34},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug","A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module","Baseline up to Day 15",{"measure":14,"description":15,"timeFrame":12},"Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug","A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module",{"measure":17,"description":18,"timeFrame":12},"Number of Participants with adverse events (AEs)","An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.",[20,24,26,28,30,32],{"measure":21,"description":22,"timeFrame":23},"Under the Serum Concentration-time Curve (AUC) of IBI3032","To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.","Predose up to 168 hours postdose",{"measure":25,"description":22,"timeFrame":23},"maximum concentration (Cmax) of IBI3032",{"measure":27,"description":22,"timeFrame":23},"time to maximum concentration (Tmax) of IBI3032",{"measure":29,"description":22,"timeFrame":23},"clearance (CL) of IBI3032",{"measure":31,"description":22,"timeFrame":23},"apparent volume of distribution (V) of IBI3032",{"measure":33,"description":22,"timeFrame":23},"elimination half-life (T1\u002F2) of IBI3032",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","SEQUENTIAL","OTHER",{"masking":40,"maskingDescription":34,"whoMasked":41},"DOUBLE",[42,43],"PARTICIPANT","INVESTIGATOR",[45,51,55,61,65,69,73,77],{"label":46,"type":47,"description":48,"interventionNames":49},"Single dose4 of IBI3032 administered orally.","EXPERIMENTAL","dose4 IBI3032",[50],"Drug: IBI3032",{"label":52,"type":47,"description":53,"interventionNames":54},"Single dose3 of IBI3032 administered orally.","dose3 IBI3032",[50],{"label":56,"type":57,"description":58,"interventionNames":59},"Single dose4 of placebo administered orally.","PLACEBO_COMPARATOR","dose4 placebo",[60],"Drug: placebo",{"label":62,"type":47,"description":63,"interventionNames":64},"Single dose1 of IBI3032 administered orally.","dose1 IBI3032",[50],{"label":66,"type":57,"description":67,"interventionNames":68},"Single dose3 of placebo administered orally.","dose3 placebo",[60],{"label":70,"type":57,"description":71,"interventionNames":72},"Single dose1 of placebo administered orally.","dose1 placebo",[60],{"label":74,"type":47,"description":75,"interventionNames":76},"Single dose2 of IBI3032 administered orally.","dose2 IBI3032",[50],{"label":78,"type":57,"description":79,"interventionNames":80},"Single dose2 of placebo administered orally.","dose2 placebo",[60],[82,87],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":34},"DRUG","IBI3032","IBI3032:\n\nMethod of administration: oral, fasted administration.",[62,74,52,46],{"type":83,"name":88,"description":89,"armGroupLabels":90,"otherNames":34},"placebo","Placebo (without active ingredients) Method of administration: oral, fasted administration.",[70,78,66,56],[92],{"name":93,"role":94,"phone":95,"phoneExt":34,"email":96},"lily Zhang","CONTACT","13603216253","lily.zhang@innoventbio.com",[98],{"facility":99,"status":100,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"ICON Clinical Research","RECRUITING","Lenexa","Kansas","66219","United States","US",{"type":107,"coordinates":108},"Point",[109,110],-94.73357,38.95362,{"lat":110,"lon":109},[113],{"name":114,"role":94,"phone":115,"phoneExt":34,"email":116},"Seth Price","913-205-4397","Seth.Price@iconplc.com",{"type":118,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100602201","phase-1-a-study-of-ibi3032-in-healthy-participants-100602201",false,"NCT07120425","A Study of IBI3032 in Healthy Participants","A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBI3032 in Healthy Participants","Inclusion Criteria:\n\n* Healthy male or females, as determined by medical history\n* Have safety laboratory results within normal reference ranges\n\nExclusion Criteria:\n\n* Have known allergies toIBI3032， glucagon-like peptide-1 (GLP-1) analogs, related compounds\n* Abnormal electrocardiogram (ECG) at screening\n* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.",true,"ALL","18 Years","65 Years",{"count":131,"type":132},32,"ESTIMATED","INTERVENTIONAL",[135],"PHASE1","This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, and PK of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 32 healthy participants are expected to be enrolled in this study.\n\nThe screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Each cohort consisted of 8 healthy participants who will be randomized in a 6:2 ratio to receive a single dose of IBI3032 or placebo. The safety follow-up period is 15 days. This study is for research purposes only, and is not intended to treat any medical condition.",[138],"Healthy","2025-09-11",{"date":141,"type":142},"2025-09-17","ACTUAL",{"date":144,"type":142},"2025-09-10",{"date":146,"type":132},"2025-11-13",{"name":5,"class":6},1]