A Study of IBI3032 in Healthy Participants

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: IBI3032; Drug: placebo

• Registration Number: NCT07120425
• Lead Sponsor: Fortvita Biologics (USA)Inc.

Brief Summary

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.

The 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-09-01
• Primary Completion: 2025-11-13
• Study Completion: 2025-11-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Healthy male or females, as determined by medical history
• Have safety laboratory results within normal reference ranges

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single dose4 of IBI3032 administered orally.	IBI3032	dose4 IBI3032
Single dose3 of IBI3032 administered orally.	IBI3032	dose3 IBI3032
Single dose4 of placebo administered orally.	placebo	dose4 placebo
Single dose1 of IBI3032 administered orally.	IBI3032	dose1 IBI3032
Single dose3 of placebo administered orally.	placebo	dose3 placebo
Single dose1 of placebo administered orally.	placebo	dose1 placebo
Single dose2 of IBI3032 administered orally.	IBI3032	dose2 IBI3032
Single dose2 of placebo administered orally.	placebo	dose2 placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug	Baseline up to Day 15	A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	Baseline up to Day 15	A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with adverse events (AEs)	Baseline up to Day 15	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.

Secondary Outcome Measures

Name	Time	Method
Under the Serum Concentration-time Curve (AUC) of IBI3032	Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
maximum concentration (Cmax) of IBI3032	Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
time to maximum concentration (Tmax) of IBI3032	Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
clearance (CL) of IBI3032	Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
apparent volume of distribution (V) of IBI3032	Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
elimination half-life (T1/2) of IBI3032	Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.

Trial Locations

Locations (1)

ICON Clinical Research; 🇺🇸 Lenexa, Kansas, United States