Single-dose IBI3032 safety and PK test in healthy adults
Official title: A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBI3032 in Healthy Participants
Run by Fortvita Biologics (USA)Inc. · NCT07120425 · Data updated 2026-11-12
This test gives a single dose of IBI3032 or placebo to healthy adults to see if it is safe and how the body processes it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Fortvita Biologics (USA)Inc. Industry-sponsored |
| Locations | 1 site (Lenexa, Kansas) |
| Status | Recruiting |
| Started | September 10, 2025 |
| Main results expected | November 13, 2025 |
| Study ends | November 13, 2025 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT07120425 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults with normal laboratory results, no significant medical history, a normal ECG, and willingness to attend screening, dosing, and follow-up visits at the study site.
✕Probably not a fit
People with significant cardiovascular, respiratory, hepatic, renal, endocrine, hematologic, or neurological disorders, abnormal ECGs, or known allergies to GLP-1 analogs are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 1 single ascending dose study enrolling about 32 healthy adults. Participants are grouped into four cohorts of eight and randomized 6:2 to receive one dose of IBI3032 or placebo after a 4-week screening period, with a 15-day safety follow-up. The trial's primary focus is safety and tolerability, with pharmacokinetic measurements to characterize how the drug is absorbed, distributed, and eliminated. People with significant medical conditions, abnormal ECGs, or known allergies to GLP-1 analogs are excluded.
Why it matters
Potential benefit: If successful, the results could identify a safe dose and pharmacokinetic profile to support further development of IBI3032 as a GLP-1–based therapy.
How similar studies have gone: Early single-dose Phase 1 studies of other GLP-1 analogs have successfully established safety and PK profiles that supported later efficacy trials, so this approach is well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
ICON Clinical Research
Lenexa, Kansas, United States Recruiting
Study contacts
- Study coordinator: lily Zhang
- Email: lily.zhang@innoventbio.com
- Phone: 13603216253
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.