Trials / Active Not Recruiting
Active Not RecruitingNCT07193147
Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment
A Single Dose Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Gan & Lee Pharmaceuticals. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
This is a multicenter, single-dose, open-label, parallel Phase 1 clinical study to evaluate the PK profile, safety, and tolerability of GZR4 Injection in subjects with mild, moderate, and severe hepatic impairment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GZR4 | GZR4 s.c., single-dose |
Timeline
- Start date
- 2025-10-20
- Primary completion
- 2026-07-14
- Completion
- 2026-11-04
- First posted
- 2025-09-25
- Last updated
- 2025-11-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07193147. Inclusion in this directory is not an endorsement.