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NOT YET RECRUITING
NCT07322016
PHASE1

A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function

Sponsor: Shandong Suncadia Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.

Official title: A Single-dose, Open-label Phase I Clinical Trial Comparing the Pharmacokinetics, Safety and Pharmacodynamics of HRS-1301 Tablets in Subjects With Mild, Moderate and Severe Renal Insufficiency and Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-01

Completion Date

2026-10

Last Updated

2026-01-07

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

HRS-1301 Tablet

HRS-1301 tablet, oral medication.

Locations (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China