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Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07120425

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

Led by Fortvita Biologics (USA)Inc. · Updated on 2025-09-17

32

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a randomized, double-blind, placebo-controlled Phase I study to evaluate the safety, tolerability, and pharmacokinetics of a single dose of IBI3032 in healthy adults. This study is a single ascending dose trial involving approximately 32 healthy participants and is intended for research purposes only, not treatment of any condition. Participants will be divided into four groups cohorts of eight people each. In each cohort, six participants will receive a single oral dose of IBI3032, and two will receive a placebo, all given while fasting. The different cohorts will receive escalating doses of IBI3032 or placebo. The study includes a screening period of four weeks, followed by dosing and then a safety follow-up lasting 15 days. During the study, participants will undergo safety and laboratory assessments to ensure they are healthy and monitor any adverse effects from the drug or placebo. Researchers will track serious and non-serious adverse events up to 15 days after dosing. Blood samples will be collected up to 168 hours post-dose to study how the drug is processed in the body. Overall participation will last through the screening, dosing, and 15-day safety follow-up periods.

CONDITIONS

Brief Title

A Study of IBI3032 in Healthy Participants

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male or female participants as determined by medical history
  • Safety laboratory results within normal reference ranges
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Known allergies to IBI3032, glucagon-like peptide-1 (GLP-1) analogs, or related compounds
  • Abnormal electrocardiogram (ECG) at screening
  • Significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders

Research Team

L

lily Zhang

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