NCT07120425PHASE1RecruitingAccepts Healthy Volunteers

A Study of IBI3032 in Healthy Participants

Fortvita Biologics (USA)Inc.

Start Date

9/10/2025

Completion Date

11/13/2025

Summary

This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, and PK of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 32 healthy participants are expected to be enrolled in this study. The screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Each cohort 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. This study is for research purposes only, and is not intended to treat any medical condition.

Eligibility Criteria

Age Range: 18 years to 65 years

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.

Interventions

DRUG

IBI3032

DRUG

placebo

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Conditions

Healthy

Locations

ICON Clinical Research

Lenexa, Kansas 66219

United States