A Study of IBI3032 in Chinese Healthy Subjects

NCT07134127 | Completed Early Phase 1

• 1 other identifier: CIBI3032T001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Under the Serum Concentration-time Curve (AUC) of IBI3032

  Predose up to 168 hours postdose

• maximum concentration (Cmax) of IBI3032

  Predose up to 168 hours postdose

• time to maximum concentration (Tmax) of IBI3032

  Predose up to 168 hours postdose

• clearance (CL) of IBI3032

  Predose up to 168 hours postdose

• apparent volume of distribution (V) of IBI3032

  Predose up to 168 hours postdose

Study Arms (10)

Single dose1 of IBI3032 administered orally.

EXPERIMENTAL

dose1 IBI3032

Drug: IBI3032

Single dose4 of placebo administered orally.

PLACEBO COMPARATOR

dose4 placebo

Drug: placebo

Single dose4 of IBI3032 administered orally.

EXPERIMENTAL

dose4 IBI3032

Drug: IBI3032

D1:Single dose3-1 of placebo administered orally. D9:Single dose3-1 of placebo administered orally.

ACTIVE COMPARATOR

D1: Fasted administer D9:Administer after meal

Drug: placebo

Single dose2 of IBI3032 administered orally.

EXPERIMENTAL

dose2 IBI3032

Drug: IBI3032

D1:Single dose3-2 of placebo administered orally. D9:Single dose3-2 of placebo administered orally.

ACTIVE COMPARATOR

D1:Administer after meal D9: Fasted administer

Drug: placebo

D1:Single dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally.

EXPERIMENTAL

D1:Administer after meal D9: Fasted administer

Drug: IBI3032

D1:Single dose3-1 of IBI3032 administered orally. D9:Single dose3-1 of IBI3032 administered orally.

EXPERIMENTAL

D1: Fasted administer D9:Administer after meal

Drug: IBI3032

Single dose1 of placebo administered orally.

PLACEBO COMPARATOR

dose1 placebo

Drug: placebo

Single dose2 of placebo administered orally.

PLACEBO COMPARATOR

dose2 placebo

Drug: placebo

Interventions

placebo DRUG

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.

D1:Single dose3-1 of placebo administered orally. D9:Single dose3-1 of placebo administered orally.; D1:Single dose3-2 of placebo administered orally. D9:Single dose3-2 of placebo administered orally.; Single dose1 of placebo administered orally.; Single dose2 of placebo administered orally.; Single dose4 of placebo administered orally.

IBI3032 DRUG

IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal.

D1:Single dose3-1 of IBI3032 administered orally. D9:Single dose3-1 of IBI3032 administered orally.; D1:Single dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally.; Single dose1 of IBI3032 administered orally.; Single dose2 of IBI3032 administered orally.; Single dose4 of IBI3032 administered orally.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Frist Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: August 29, 2025
• Primary Completion: October 7, 2025
• Study Completion: October 7, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)