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A Study of IBI3032 in Chinese Healthy Subjects

NCT07134127 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-29
Primary Completion
2025-10-07
Completion
2025-10-07

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07134127 on ClinicalTrials.gov