NCT07134127

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2025-08-29
• Primary completion: 2025-10-07
• Completion: 2025-10-07
• First posted: 2025-08-21
• Last updated: 2025-11-17

Locations

1 site across 1 country: China