drugset / Trial / NCT06841731
A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.
Timeline
- Start
- 2025-04-03
- Primary completion
- 2026-02
- Completion
- 2026-02
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.
- Wu Y, Han Q, Yang H, Xue J, Wang L, Mao X, Yin T, Jiang H, Xu S, Huang Y, Wang T, He Y, Luo Y, Chen W, Zhang J. Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0109525. doi: 10.1128/aac.01095-25. Epub 2026 Jan 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HRS-8427 | Small molecule | — | Intravenous |
| Comparator | Meropenem | Small molecule | — | — |