Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency

Summary

The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function. The study was divided into three parts: Part 1: single ascending dose, randomized, double-blind study，with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions; Part 2: Multiple ascending dose, randomized, double-blind study，with 4 dose groups preset; Part 3: an open-label, nonrandomized, single-dose study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS -5965 compared to demographically-matched healthy participants with normal renal function.

Timeline

Start

2022-10-08

Primary completion

2023-11-03

Completion

2023-11-03

Publications

• Xu Y, Tian F, Ren H, Yu X, Chen X, Ye K, Sun F, Fang L, Li Y, Ban R, Jiang X, Wang C, Ma Y, Kuang F, Li X, Zhang Z, Ye C, Hu M, He F, Shu C, Zou Y, Huang R, Shen K, Xing G, Cao Y. HRS-5965, a small-molecule factor B inhibitor, in healthy participants and participants with renal insufficiency: A first-in-human, phase 1 trial. Med. 2025 Aug 8;6(8):100698. doi: 10.1016/j.medj.2025.100698. Epub 2025 May 15.

Drugs

Indications