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ACTIVE NOT RECRUITING
NCT07193147
PHASE1

Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment

Sponsor: Gan & Lee Pharmaceuticals.

View on ClinicalTrials.gov

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.

Official title: A Single Dose Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-10-20

Completion Date

2026-11-04

Last Updated

2025-11-28

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

GZR4

GZR4 s.c., single-dose

Locations (1)

Gan & Lee Pharmaceuticals Shandong Co., Ltd.

Linyi, Shandong, China