CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 33 enrolled
Drug / intervention
HRS-8427drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07070375
NCT07070375Phase 1Completed
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A Multicenter, Parallel-Group, Open-Label Study of Pharmacokinetics and Safety of HRS-8427 Injection in Chinese Subjects With Renal Impairment

Jiangsu HengRui Medicine Co., Ltd.·interventional·Posted Jul 17, 2025·Updated Jul 17, 2025

In Brief

A Phase 1 clinical trial evaluating HRS-8427 for Gram-negative Bacterial Infections. Completed, enrolled 33 participants across 1 site.

Detailed Summary

This study evaluated the pharmacokinetic profile, safety, and tolerability of HRS-8427 injection in subjects with mild, moderate, severe, or end-stage renal disease (ESRD) requiring dialysis, using subjects with normal renal function as controls, to inform clinical dosing in patients with renal impairment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGram-negative Bacterial Infections
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedJul 17, 2025
Enrollment StartApr 19, 2023
Primary CompletionAug 23, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12 months ago

Interventions

HRS-8427drug

HRS-8427