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

NCT06657560 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-07-18

No results posted yet for this study

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

DRUG

HRS-9231

HRS-9231

Sponsors & Collaborators

  • Shanghai Shengdi Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-14
Primary Completion
2025-07-03
Completion
2025-07-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06657560 on ClinicalTrials.gov