Recruiting
Phase 1

IBI3032

Sponsor:

Fortvita Biologics (USA)Inc.

Code:

NCT07120425

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

IBI3032

placebo

Study Details

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

Study ID

NCT07120425

Start date

Sep 10, 2025

Status verified date

Sep, 2025

Completion date

Nov 13, 2025

Anticipated

Primary completion date

Nov 13, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Single dose4 of IBI3032 administered orally.

dose4 IBI3032

experimental: Single dose3 of IBI3032 administered orally.

dose3 IBI3032

placebo comparator: Single dose4 of placebo administered orally.

dose4 placebo

experimental: Single dose1 of IBI3032 administered orally.

dose1 IBI3032

placebo comparator: Single dose3 of placebo administered orally.

dose3 placebo

placebo comparator: Single dose1 of placebo administered orally.

dose1 placebo

experimental: Single dose2 of IBI3032 administered orally.

dose2 IBI3032

placebo comparator: Single dose2 of placebo administered orally.

dose2 placebo

Interventions

IBI3032

IBI3032:

Method of administration: oral, fasted administration.

placebo

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

Primary outcome measure

  • 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 ]
  • 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 ]
  • Number of Participants with adverse events (AEs) [ Time Frame: Baseline up to Day 15 ]

Central Contacts and Locations

Central contacts

lily Zhang

13603216253lily.zhang@innoventbio.com

Locations

ICON Clinical Research

Recruiting

Lenexa, Kansas, United States, 66219

Contacts

Seth Price

913-205-4397Seth.Price@iconplc.com

More Information

Sponsor

Fortvita Biologics (USA)Inc.

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fortvita Biologics (USA)Inc. on 2025-09-17.