A Study of IBI3032 in Healthy Participants

September 11, 2025 updated by: Fortvita Biologics (USA)Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single dose4 of IBI3032 administered orally.
dose4 IBI3032
Drug: IBI3032

IBI3032:

Method of administration: oral, fasted administration.
Experimental: Single dose3 of IBI3032 administered orally.
dose3 IBI3032
Drug: IBI3032

IBI3032:

Method of administration: oral, fasted administration.
Placebo Comparator: Single dose4 of placebo administered orally.
dose4 placebo
Drug: placebo
Placebo (without active ingredients) Method of administration: oral, fasted administration.
Experimental: Single dose1 of IBI3032 administered orally.
dose1 IBI3032
Drug: IBI3032

IBI3032:

Method of administration: oral, fasted administration.
Placebo Comparator: Single dose3 of placebo administered orally.
dose3 placebo
Drug: placebo
Placebo (without active ingredients) Method of administration: oral, fasted administration.
Placebo Comparator: Single dose1 of placebo administered orally.
dose1 placebo
Drug: placebo
Placebo (without active ingredients) Method of administration: oral, fasted administration.
Experimental: Single dose2 of IBI3032 administered orally.
dose2 IBI3032
Drug: IBI3032

IBI3032:

Method of administration: oral, fasted administration.
Placebo Comparator: Single dose2 of placebo administered orally.
dose2 placebo
Drug: placebo
Placebo (without active ingredients) Method of administration: oral, fasted administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
Time Frame: Baseline up to Day 15
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Baseline up to Day 15
Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Time Frame: Baseline up to Day 15
A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Baseline up to Day 15
Number of Participants with adverse events (AEs)
Time Frame: Baseline up to Day 15
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Baseline up to Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Under the Serum Concentration-time Curve (AUC) of IBI3032
Time Frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Predose up to 168 hours postdose
maximum concentration (Cmax) of IBI3032
Time Frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Predose up to 168 hours postdose
time to maximum concentration (Tmax) of IBI3032
Time Frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Predose up to 168 hours postdose
clearance (CL) of IBI3032
Time Frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Predose up to 168 hours postdose
apparent volume of distribution (V) of IBI3032
Time Frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Predose up to 168 hours postdose
elimination half-life (T1/2) of IBI3032
Time Frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Predose up to 168 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fortvita Biologics (USA)Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2025

Primary Completion (Estimated)

November 13, 2025

Study Completion (Estimated)

November 13, 2025

Study Registration Dates

First Submitted

August 6, 2025

First Submitted That Met QC Criteria

August 6, 2025

First Posted (Actual)

August 13, 2025

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI3032A102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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