A Study of IBI3032 in Healthy Participants

NCT07120425 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CIBI3032A102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug

  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

  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)

  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 Outcomes (6)

• Under the Serum Concentration-time Curve (AUC) of IBI3032

  Predose up to 168 hours postdose

• maximum concentration (Cmax) of IBI3032

  Predose up to 168 hours postdose

• time to maximum concentration (Tmax) of IBI3032

  Predose up to 168 hours postdose

• clearance (CL) of IBI3032

  Predose up to 168 hours postdose

• apparent volume of distribution (V) of IBI3032

  Predose up to 168 hours postdose

Study Arms (8)

Single dose4 of IBI3032 administered orally.

EXPERIMENTAL

dose4 IBI3032

Drug: IBI3032

Single dose3 of IBI3032 administered orally.

EXPERIMENTAL

dose3 IBI3032

Drug: IBI3032

Single dose4 of placebo administered orally.

PLACEBO COMPARATOR

dose4 placebo

Drug: placebo

Single dose1 of IBI3032 administered orally.

EXPERIMENTAL

dose1 IBI3032

Drug: IBI3032

Single dose3 of placebo administered orally.

PLACEBO COMPARATOR

dose3 placebo

Drug: placebo

Single dose1 of placebo administered orally.

PLACEBO COMPARATOR

dose1 placebo

Drug: placebo

Single dose2 of IBI3032 administered orally.

EXPERIMENTAL

dose2 IBI3032

Drug: IBI3032

Single dose2 of placebo administered orally.

PLACEBO COMPARATOR

dose2 placebo

Drug: placebo

Interventions

IBI3032 DRUG

IBI3032: Method of administration: oral, fasted administration.

Single dose1 of IBI3032 administered orally.; Single dose2 of IBI3032 administered orally.; Single dose3 of IBI3032 administered orally.; Single dose4 of IBI3032 administered orally.

placebo DRUG

Placebo (without active ingredients) Method of administration: oral, fasted administration.

Single dose1 of placebo administered orally.; Single dose2 of placebo administered orally.; Single dose3 of placebo administered orally.; Single dose4 of placebo administered orally.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or females, as determined by medical history
• Have safety laboratory results within normal reference ranges

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fortvita Biologics (USA)Inc.: lead

Study Sites (1)

ICON Clinical Research

Lenexa, Kansas, 66219, United States

RECRUITING

Central Study Contacts

lily Zhang

CONTACT

13603216253; lily.zhang@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: September 10, 2025
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)