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

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).

Timeline

Start

2025-08-12

Primary completion

2026-07-12

Completion

2027-01-26

Drugs

Indications