NCT07322016

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperlipidemias

Interventions

Type	Name	Description
DRUG	HRS-1301 Tablet	HRS-1301 tablet, oral medication.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: China