Clinical Trial

A Study of IBI3032 in Healthy Participants

Recruiting Phase 1
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Record status
This record was last updated September 17, 2025 (before its estimated November 13, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-06.
Status change: Not Yet Recruiting → Recruiting 2025-09-11
Trial Details
NCT Number NCT07120425
Lead Sponsor Fortvita Biologics (USA)Inc.
Conditions Healthy
Enrollment 32 participants
Start Date 2025-09-10
Primary Completion 2025-11-13 (estimated)
Study Completion 2025-11-13 (estimated)
Updated on ClinicalTrials.gov 2025-09-17