[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657604":3},{"organization":4,"outcomesModule":7,"designInfo":89,"detailedDescription":78,"studyPopulation":78,"armGroups":99,"interventions":112,"overallOfficials":78,"centralContacts":118,"locations":124,"responsibleParty":146,"collaborators":78,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":78,"eligibilityCriteria":154,"healthyVolunteers":155,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":78,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":174,"whyStopped":78,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"Fortvita Biologics (USA)Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":75,"otherOutcomes":78},[9,13,15,18,21,24,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72],{"measure":10,"description":11,"timeFrame":12},"Number of Participants With Adverse Events","Number of Participants With Adverse Events.","through study completion, an average of 29 days",{"measure":14,"description":14,"timeFrame":12},"Number of Participants With Clinically Significant Abnormal Vital Signs",{"measure":16,"description":17,"timeFrame":12},"Number of Participants With Clinically Significant Abnormal 12-lead electrocardiogram","Number of participants with at least one clinically significant abnormal finding on resting 12-lead electrocardiogram(ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECGrecording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF(QTcF=QT\u002FRR\\^0.33).",{"measure":19,"description":20,"timeFrame":12},"Number of Participants With Abnormal General Appearance Findings","Number of participants with at least one clinically significant abnormal finding in general appearance on physical examination.",{"measure":22,"description":23,"timeFrame":12},"Number of Participants With Abnormal Respiratory Findings","Number of participants with at least one clinically significant abnormal finding in respiratory tract assessment on physical examination.",{"measure":25,"description":26,"timeFrame":12},"Number of Participants With Abnormal Cardiovascular Findings","Number of participants with at least one clinically significant abnormal finding in cardiovascular assessment on physical examination.",{"measure":28,"description":29,"timeFrame":12},"Number of Participants With Abnormal Abdominal Findings","Number of participants with at least one clinically significant abnormal finding in abdominal assessment on physical examination.",{"measure":31,"description":32,"timeFrame":12},"Number of Participants With Abnormal Skin Findings","Number of participants with at least one clinically significant abnormal finding in skin assessment on physical examination.",{"measure":34,"description":35,"timeFrame":12},"Number of Participants With Abnormal Head and Neck Findings","Number of participants with at least one clinically significant abnormal finding in head and neck (ear, eye, nose, throat) assessment on physical examination.",{"measure":37,"description":38,"timeFrame":12},"Number of Participants With Abnormal Lymph Node Findings","Number of participants with at least one clinically significant abnormal finding in lymph node assessment on physical examination.",{"measure":40,"description":41,"timeFrame":12},"Number of Participants With Abnormal Thyroid Findings","Number of participants with at least one clinically significant abnormal finding in thyroid assessment on physical examination.",{"measure":43,"description":44,"timeFrame":12},"Number of Participants With Abnormal Musculoskeletal Findings","Number of participants with at least one clinically significant abnormal finding in musculoskeletal (spine and extremities) assessment on physical examination.",{"measure":46,"description":47,"timeFrame":12},"Number of Participants With Abnormal Neurological Findings","Number of participants with at least one clinically significant abnormal finding in neurological assessment on physical examination.",{"measure":49,"description":50,"timeFrame":12},"Number of Participants With Abnormal Blood Routine Findings","Number of participants with at least one clinically significant abnormal finding in blood routine tests.",{"measure":52,"description":53,"timeFrame":12},"Number of Participants With Abnormal Blood Biochemistry Findings","Number of participants with at least one clinically significant abnormal finding in blood biochemistry tests, including blood lipids.",{"measure":55,"description":56,"timeFrame":12},"Number of Participants With Abnormal Coagulation Findings","Number of participants with at least one clinically significant abnormal finding in coagulation routine tests.",{"measure":58,"description":59,"timeFrame":12},"Number of Participants With Abnormal Urine Routine Findings","Number of participants with at least one clinically significant abnormal finding in urine routine tests.",{"measure":61,"description":62,"timeFrame":12},"Number of Participants With Abnormal Calcitonin Findings","Number of participants with at least one clinically significant abnormal finding in calcitonin test.",{"measure":64,"description":65,"timeFrame":12},"Number of Participants With Abnormal Glycated Hemoglobin Findings","Number of participants with at least one clinically significant abnormal finding in glycated hemoglobin (HbA1c) test.",{"measure":67,"description":68,"timeFrame":12},"Number of Participants With Abnormal Infection-Related Immunology Findings","Number of participants with at least one clinically significant abnormal finding in infection-related immunology tests.",{"measure":70,"description":71,"timeFrame":12},"Number of Participants With Abnormal Thyroid Function Findings","Number of participants with at least one clinically significant abnormal finding in thyroid function tests.",{"measure":73,"description":74,"timeFrame":12},"Number of Participants With Abnormal Pregnancy Test Findings","Number of participants with at least one clinically significant abnormal finding in pregnancy test.",[76,79,81,83,85,87],{"measure":77,"description":78,"timeFrame":12},"Area Under the Plasma Concentration Time Curve (AUC)",null,{"measure":80,"description":78,"timeFrame":12},"Peak Plasma Concentration (Cmax)",{"measure":82,"description":78,"timeFrame":12},"Time to Reach Peak Plasma Concentration (Tmax)",{"measure":84,"description":78,"timeFrame":12},"Apparent Clearance (CL\u002FF)",{"measure":86,"description":78,"timeFrame":12},"Apparent Volume of Distribution (Vz\u002FF)",{"measure":88,"description":78,"timeFrame":12},"Terminal Half-Life (T1\u002F2)",{"allocation":90,"interventionModel":91,"interventionModelDescription":78,"primaryPurpose":92,"observationalModel":78,"timePerspective":78,"maskingInfo":93},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":94,"maskingDescription":78,"whoMasked":95},"TRIPLE",[96,97,98],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[100,106],{"label":101,"type":102,"description":103,"interventionNames":104},"Matching Placebo","PLACEBO_COMPARATOR","Oral, matching to IBI3042, corresponding dose regimen according to study cohort",[105],"Drug: Matching Placebo",{"label":107,"type":108,"description":109,"interventionNames":110},"Investigational Drug: IBI3042","EXPERIMENTAL","Oral, corresponding dose regimen according to study cohort",[111],"Drug: Investigational Drug: IBI3042",[113,116],{"type":114,"name":107,"description":109,"armGroupLabels":115,"otherNames":78},"DRUG",[107],{"type":114,"name":101,"description":103,"armGroupLabels":117,"otherNames":78},[101],[119],{"name":120,"role":121,"phone":122,"phoneExt":78,"email":123},"Dee Li","CONTACT","+86 18017984650","dee.li@innoventbio.com",[125],{"facility":126,"status":78,"city":127,"state":128,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":137,"contacts":138},"ICON Lenexa","Lenexa","Kansas","66219","United States","US",{"type":133,"coordinates":134},"Point",[135,136],-94.73357,38.95362,{"lat":136,"lon":135},[139,143],{"name":140,"role":121,"phone":141,"phoneExt":78,"email":142},"Pactrick Yao","+1 913 574 6457","Patrick.Yao@iconplc.com",{"name":144,"role":145,"phone":78,"phoneExt":78,"email":78},"Pactrick Yao, PhD","PRINCIPAL_INVESTIGATOR",{"type":147,"investigatorFullName":78,"investigatorTitle":78,"investigatorAffiliation":78,"oldNameTitle":78,"oldOrganization":78},"SPONSOR","100657604","phase-1-a-study-of-ibi3042-in-healthy-adult-participants-100657604",false,"NCT07842393","A Study of IBI3042 in Healthy Adult Participants","A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of IBI3042 in Healthy Adult Participants","Inclusion Criteria:\n\n* Aged 18 to 55 years, inclusive.\n* BMI ≥20 and \\\u003C32 kg\u002Fm² and body weight ≥50 kg;\n* Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.\n* Able and willing to comply with study procedures and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.\n* History of diabetes or abnormal glycemic parameters at screening.\n* Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng\u002FL at screening.\n* History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.\n* Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening.\n* Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments.\n* Clinically significant abnormalities in physical examination or laboratory tests at screening.\n* History of malignancy within 5 years, except for basal cell or squamous cell skin cancer.\n* Use of prescription or over-the-counter medications, or dietary supplement vitamins within 2 weeks or 5 half-lives, whichever is greater, prior to screening; or use of any herbal products within 4 weeks prior to screening.\n* Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable.\n* Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.",true,"ALL","18 Years","55 Years",{"count":160,"type":161},32,"ESTIMATED","INTERVENTIONAL",[164],"PHASE1","This is a randomized, investigator- and participant-blinded, placebo-controlled, parallel-group, dose-escalation Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of IBI3042, in healthy adult participants. Approximately 32 healthy participants will be enrolled across 4 single ascending dose groups, with 8 participants per group randomized in a 6:2 ratio to receive a single oral dose of IBI3042 or matching placebo. A sentinel-dosing design is used for the first dose cohort. Safety and PK data are assessed to support dose escalation decisions by the Safety Review Committee.",[167],"Healthy Volunteers (HV)",[169,170,171,172,173],"Glucagon-Like Peptide 1 Receptor Agonists","Healthy Volunteers","Phase 1 Clinical Trials","Pharmacokinetics","Safety","NOT_YET_RECRUITING","2026-09-21",{"date":177,"type":178},"2026-09-25","ACTUAL",{"date":180,"type":161},"2026-09-29",{"date":182,"type":161},"2027-02-03",{"name":5,"class":6},1]