RECRUITING

A Study of IBI3032 in Healthy Participants

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-10
Study Completion:2025-11-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07120425

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy male or females, as determined by medical history
  2. * Have safety laboratory results within normal reference ranges
  1. * Have known allergies toIBI3032, glucagon-like peptide-1 (GLP-1) analogs, related compounds
  2. * Abnormal electrocardiogram (ECG) at screening
  3. * Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.

Contacts and Locations

Study Contact

lily Zhang
CONTACT
13603216253
lily.zhang@innoventbio.com

Study Locations (Sites)

ICON Clinical Research
Lenexa, Kansas, 66219
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-09-10
Study Completion Date2025-11-13

Study Record Updates

Study Start Date2025-09-10
Study Completion Date2025-11-13

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy