[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07120425":3,"trial-entities:NCT07120425":111,"trial-summary:NCT07120425":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":46,"secondary_outcomes":57,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":15,"eligibility_criteria":75,"std_ages":84,"locations":87,"central_contacts":103,"overall_officials":108,"references":109,"see_also_links":110},"NCT07120425","CIBI3032A102","A Study of IBI3032 in Healthy Participants","A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBI3032 in Healthy Participants","RECRUITING","2025-11-13","2025-09","2025-09-17","2025-09-10","Fortvita Biologics (USA)Inc.","INDUSTRY",true,"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.",null,[19],"Healthy",[],"INTERVENTIONAL","OTHER",[24],"PHASE1",{"count":26,"type":27},32,"ESTIMATED",[29,38],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","IBI3032","IBI3032:\n\nMethod of administration: oral, fasted administration.",[34,35,36,37],"Single dose1 of IBI3032 administered orally.","Single dose2 of IBI3032 administered orally.","Single dose3 of IBI3032 administered orally.","Single dose4 of IBI3032 administered orally.",{"type":30,"name":39,"description":40,"armGroupLabels":41},"placebo","Placebo (without active ingredients) Method of administration: oral, fasted administration.",[42,43,44,45],"Single dose1 of placebo administered orally.","Single dose2 of placebo administered orally.","Single dose3 of placebo administered orally.","Single dose4 of placebo administered orally.",[47,51,54],{"measure":48,"description":49,"timeFrame":50},"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":52,"description":53,"timeFrame":50},"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":55,"description":56,"timeFrame":50},"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.",[58,62,64,66,68,70],{"measure":59,"description":60,"timeFrame":61},"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":63,"description":60,"timeFrame":61},"maximum concentration (Cmax) of IBI3032",{"measure":65,"description":60,"timeFrame":61},"time to maximum concentration (Tmax) of IBI3032",{"measure":67,"description":60,"timeFrame":61},"clearance (CL) of IBI3032",{"measure":69,"description":60,"timeFrame":61},"apparent volume of distribution (V) of IBI3032",{"measure":71,"description":60,"timeFrame":61},"elimination half-life (T1\u002F2) of IBI3032","ALL","18 Years","65 Years",{"inclusion":76,"exclusion":79,"raw_text":83},[77,78],"Healthy male or females, as determined by medical history","Have safety laboratory results within normal reference ranges",[80,81,82],"Have known allergies toIBI3032， glucagon-like peptide-1 (GLP-1) analogs, related compounds","Abnormal electrocardiogram (ECG) at screening","Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.","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.",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"status":8,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":100},"ICON Clinical Research","Lenexa","Kansas","66219","United States",[95],{"name":96,"role":97,"phone":98,"email":99},"Seth Price","CONTACT","913-205-4397","Seth.Price@iconplc.com",{"lat":101,"lon":102},38.95362,-94.73357,[104],{"name":105,"role":97,"phone":106,"email":107},"lily Zhang","13603216253","lily.zhang@innoventbio.com",[],[],[],{"nct_id":4,"conditions":112,"biomarkers":113},[19],[],{"nct_id":4,"found":15,"summary":115,"prompt_version":123},{"design":116,"status":117,"heading":6,"summary":118,"follow_up":116,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"Not specified.","completed","{\n   \"A Study of IBI3032 in Healthy Participants\",\n   \"This study is testing a new drug called IBI3032 in healthy volunteers. It's a Phase I study, which means researchers are mainly looking at how safe IBI3032 is and how your body handles it. You would receive either IBI3032 or a placebo (a pill with no active medicine). The main goal is to see how many people experience side effects or serious side effects within 15 days of taking the drug. To join, you need to be a healthy male or female between 18 and 65 years old, with normal lab test results. You cannot join if you have allergies to IBI3032 or related drugs, or certain heart, lung, or kidney conditions. About 32 healthy people are expected to participate.\",\n  \"design\": \"This is a randomized, double-blind, placebo-controlled Phase I study. About 32 healthy participants will be divided into groups, with most receiving IBI3032 and some receiving a placebo.\",\n  \"commitments\": \"You would go through a screening period of up to 4 weeks. If eligible, you would receive a single dose of IBI3032 or placebo, followed by a safety check-up period of 15 days.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for safety for 15 days after receiving the study drug.\",\n}",213,"Not specified in the trial record.","Not stated in the trial record.",[31,39],"v2"]