NCT06674915

Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment

A Single-dose, Open-label, Phase I Study Comparing the Pharmacokinetics, Safety, and Pharmacodynamics of HRS-5965 in Subjects With Mild and Moderate Hepatic Impairment and Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chengdu Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function.

Conditions

• Complement Mediated Primary or Secondary Glomerular Diseases

Interventions

Type	Name	Description
DRUG	HRS-5965 capsules	Oral 50 mg.

Timeline

• Start date: 2024-11-26
• Primary completion: 2026-01-16
• Completion: 2026-01-16
• First posted: 2024-11-05
• Last updated: 2026-01-30

Locations

1 site across 1 country: China