A Study of IBI3032 in Chinese Healthy Subjects

NCT ID: NCT07134127

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-29
• Study Completion Date: 2025-10-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Single dose1 of IBI3032 administered orally.

dose1 IBI3032

Group Type: EXPERIMENTAL

IBI3032

Intervention Type: DRUG

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

Single dose4 of placebo administered orally.

dose4 placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Single dose4 of IBI3032 administered orally.

dose4 IBI3032

Group Type: EXPERIMENTAL

IBI3032

Intervention Type: 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 placebo administered orally. D9:Single dose3-1 of placebo administered orally.

D1: Fasted administer D9:Administer after meal

Group Type: ACTIVE_COMPARATOR

placebo

Intervention Type: 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.

Single dose2 of IBI3032 administered orally.

dose2 IBI3032

Group Type: EXPERIMENTAL

IBI3032

Intervention Type: DRUG

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

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

D1:Administer after meal D9: Fasted administer

Group Type: ACTIVE_COMPARATOR

placebo

Intervention Type: 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 dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally.

D1:Administer after meal D9: Fasted administer

Group Type: EXPERIMENTAL

IBI3032

Intervention Type: 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: Fasted administer D9:Administer after meal

Group Type: EXPERIMENTAL

IBI3032

Intervention Type: DRUG

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

Single dose1 of placebo administered orally.

dose1 placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Single dose2 of placebo administered orally.

dose2 placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

IBI3032

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Innovent Biologics Technology Limited (Shanghai R&D Center)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Frist Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

CIBI3032T001

Identifier Type: -

Identifier Source: org_study_id