Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency
Status:
Not yet recruiting
Trial end date:
2023-04-10
Target enrollment:
Participant gender:
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.