Single-dose IBI3032 safety and PK test in healthy adults
A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBI3032 in Healthy Participants
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 |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fortvita Biologics (USA)Inc. Industry-sponsored |
| Locations | 1 site (Lenexa, Kansas) |
| Trial ID | NCT07120425 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lenexa, Kansas
- ICON Clinical Research — Lenexa, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: lily Zhang
- Email: lily.zhang@innoventbio.com
- Phone: 13603216253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.