NCT05505955

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

A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of Single and Multiple Dose of HRS-5965 Tablets in Healthy Subjects, and the Food Effect on Pharmacokinetics, and Pharmacokinetics in Subjects With Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Chengdu Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glomerulonephritis

Interventions

Type	Name	Description
DRUG	HRS-5965	Subjects took HRS5965 tablets in Part 1, Part 2 and Part 3.
DRUG	Placebo	Subjects took Placebo in Part 1 and Part 2.

Timeline

• Start date: 2022-10-08
• Primary completion: 2023-11-03
• Completion: 2023-11-03
• First posted: 2022-08-18
• Last updated: 2024-10-23

Locations

1 site across 1 country: China