NCT06657560

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

Pharmacokinetics (PK) Study of HRS-9231 Injection in Chinese Subjects With Renal Impairment and Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contrast-Enhanced Magnetic Resonance Imaging Detection

Interventions

Type	Name	Description
DRUG	HRS-9231	HRS-9231

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-07-03
• Completion: 2025-07-03
• First posted: 2024-10-24
• Last updated: 2025-07-18

Locations

1 site across 1 country: China