Pharmacokinetics, Dialysability and Safety of HRS-9231 in Healthy Volunteers and in Patients With Impaired Renal Function

Summary

This is an open-label, non-randomized, parallel cohorts design, multicenter, single dose phase I study. The primary objectives are: To evaluate the pharmacokinetics (plasma and urine) profile of HRS-9231 following single intravenous injection (0.05 mmol/kg body weight) in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference. To assess dialysability of HRS-923 following a single intravenous injection (0.05 mmol/kg body weight) in patients with end stage renal disease requiring hemodialysis.

Timeline

Start

2024-10-14

Primary completion

2025-07-03

Completion

2025-07-03

Drugs

Indications