NCT07120425

A Study of IBI3032 in Healthy Participants

A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBI3032 in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Fortvita Biologics (USA)Inc. · 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, 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IBI3032	IBI3032: Method of administration: oral, fasted administration.
DRUG	placebo	Placebo (without active ingredients) Method of administration: oral, fasted administration.

Timeline

• Start date: 2025-09-10
• Primary completion: 2025-11-13
• Completion: 2025-11-13
• First posted: 2025-08-13
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study