drugset / Trial / NCT07070375
Pharmacokinetics and Safety of HRS-8427 in Healthy Volunteers and in Patients With Impaired Renal Function
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-04-19
- Primary completion
- 2023-08-23
- Completion
- 2023-08-23
Publications
- Yin T, Qu B, Zhang Q, Xu S, Wu Y, Jiang H, Huang Y, Hu W. Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects. Antimicrob Agents Chemother. 2026 Apr;70(4):e0069425. doi: 10.1128/aac.00694-25. Epub 2026 Mar 3.
- Cao Y, Huang Y, Xie J, Wu Q, Yang S, Yang X, Huang J, Liu J, Meng J, Yang G. Intrapulmonary penetration and pharmacokinetics of siderophore cephalosporin HRS-8427 injection in Chinese healthy subjects. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0070225. doi: 10.1128/aac.00702-25. Epub 2025 Nov 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HRS-8427 | Small molecule | — | Intravenous |