A Study of IBI3032 in Chinese Healthy Subjects

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of IBI3032 in Participants

This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, PK and food effect of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 40 healthy participants are expected to be enrolled in this study. The screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Cohort1,2,4 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. Cohort 3 consisted of 16 participants used a two-cycle, double-crossover design, who were randomly divided into four groups at a ratio of 3:1:3:1: Cohort 3-1-IBI3032, cohort 3-1-placebo, cohort 3-2-IBI3032, and cohort 3-2-placebo, each subject underwent two cycles of the trial. In cohort 3-1, the first cycle was given on fasted administration, and the second cycle was given after breakfast. In cohort 3-2, the first cycle was administered after breakfast intake, and the second cycle was administered fasted. The washout period for cohort 3-1 and cohort 3-2 was 8 days.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: IBI3032; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • The Frist Affiliated Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose4 of IBI3032 administered orally.; dose4 IBI3032	Drug: IBI3032; IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal.
Placebo Comparator: Single dose4 of placebo administered orally.; dose4 placebo	Drug: placebo; Placebo (without active ingredients) (cohort1, 2,4) Method of administration: oral, fasted administration. Placebo (without active ingredients) (cohort3) Method of administration: oral, administration after meal.
Experimental: Single dose1 of IBI3032 administered orally.; dose1 IBI3032	Drug: IBI3032; IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal.
Placebo Comparator: Single dose1 of placebo administered orally.; dose1 placebo	Drug: placebo; Placebo (without active ingredients) (cohort1, 2,4) Method of administration: oral, fasted administration. Placebo (without active ingredients) (cohort3) Method of administration: oral, administration after meal.
Experimental: Single dose2 of IBI3032 administered orally.; dose2 IBI3032	Drug: IBI3032; IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal.
Placebo Comparator: Single dose2 of placebo administered orally.; dose2 placebo	Drug: placebo; Placebo (without active ingredients) (cohort1, 2,4) Method of administration: oral, fasted administration. Placebo (without active ingredients) (cohort3) Method of administration: oral, administration after meal.
Active Comparator: D1:Single dose3-1 of placebo administered orally. D9:Single dose3-1 of placebo administered orally.; D1: Fasted administer D9:Administer after meal	Drug: placebo; Placebo (without active ingredients) (cohort1, 2,4) Method of administration: oral, fasted administration. Placebo (without active ingredients) (cohort3) Method of administration: oral, administration after meal.
Active Comparator: D1:Single dose3-2 of placebo administered orally. D9:Single dose3-2 of placebo administered orally.; D1:Administer after meal D9: Fasted administer	Drug: placebo; Placebo (without active ingredients) (cohort1, 2,4) Method of administration: oral, fasted administration. Placebo (without active ingredients) (cohort3) Method of administration: oral, administration after meal.
Experimental: D1:Single dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally.; D1:Administer after meal D9: Fasted administer	Drug: IBI3032; IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal.
Experimental: D1:Single dose3-1 of IBI3032 administered orally. D9:Single dose3-1 of IBI3032 administered orally.; D1: Fasted administer D9:Administer after meal	Drug: IBI3032; IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	(Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15
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	(Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15
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.	(Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
maximum concentration (Cmax) of IBI3032	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.	Predose up to 168 hours postdose
time to maximum concentration (Tmax) of IBI3032	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.	Predose up to 168 hours postdose
clearance (CL) of IBI3032	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.	Predose up to 168 hours postdose
apparent volume of distribution (V) of IBI3032	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.	Predose up to 168 hours postdose
elimination half-life (T1/2) of IBI3032	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.	Predose up to 168 hours postdose

Collaborators and Investigators

• Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2025
• Primary Completion (Actual): October 7, 2025
• Study Completion (Actual): October 7, 2025

Study Registration Dates

• First Submitted: August 14, 2025
• First Submitted That Met QC Criteria: August 14, 2025
• First Posted (Actual): August 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: CIBI3032T001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No