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RECRUITING
NCT07144098
PHASE1

Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function

Sponsor: Gan & Lee Pharmaceuticals.

View on ClinicalTrials.gov

Summary

This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal liver function and those with mild, moderate or severe liver insufficiency. The study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing/observation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-08-12

Completion Date

2027-01-26

Last Updated

2025-08-27

Healthy Volunteers

Yes

Interventions

DRUG

GZR18 injection

3 mg-Control group

DRUG

GZR18 injection

3 mg-mild liver insufficiency

DRUG

GZR18 injection

3 mg-moderate liver insufficiency

DRUG

GZR18 injection

3 mg-severe liver insufficiency

Locations (1)

Gan & Lee Pharmaceuticals

Beijing, China