NCT07070375

Pharmacokinetics and Safety of HRS-8427 in Healthy Volunteers and in Patients With Impaired Renal Function

A Multicenter, Parallel-Group, Open-Label Study of Pharmacokinetics and Safety of HRS-8427 Injection in Chinese Subjects With Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study evaluated the pharmacokinetic profile, safety, and tolerability of HRS-8427 injection in subjects with mild, moderate, severe, or end-stage renal disease (ESRD) requiring dialysis, using subjects with normal renal function as controls, to inform clinical dosing in patients with renal impairment.

Conditions

• Gram-negative Bacterial Infections

Interventions

Type	Name	Description
DRUG	HRS-8427	HRS-8427

Timeline

• Start date: 2023-04-19
• Primary completion: 2023-08-23
• Completion: 2023-08-23
• First posted: 2025-07-17
• Last updated: 2025-07-17

Locations

1 site across 1 country: China