Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function

Phase 1

Recruiting

• Conditions: Diabetes Mellitus
• Interventions: Drug: HRS-7535 Tables

• Registration Number: NCT06961643
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Study First Posted: 2025-05-08
• Status Verified: 2025-06
• Study Start: 2025-06-05
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-15
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing.
2. Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female.
3. At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18~32 kg/m2 (including the threshold).

Exclusion Criteria

1. In the judgment of the investigator, may be allergic to the study drug or its components.
2. Smoking an average of more than 10 cigarettes per day within 3 months prior to screening.
3. Alcoholics of within 3 months prior to screening, who consume more than 14 units of alcohol per week (1 unit=beer)360 mL of alcohol, or 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine.
4. History of drug or substance abuse, or a positive urine drug test at screening.
5. Donated or lost ≥ 400 mL of blood within 3 months prior to screening.
6. Individuals with a history of severe hypoglycemia.
7. Undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	HRS-7535 Tables	Subjects with mild hepatic impairment.
Treatment group B	HRS-7535 Tables	Subjects with moderate hepatic impairment.
Treatment group C	HRS-7535 Tables	Subjects with normal hepatic function.

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration of HRS-7535 (Cmax)	Post-dose at day 1 to day 4.
Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)	Post-dose at day 1 to day 4.
Area under the concentration curve from time 0 to the last quantifiable concentration (AUC0-t)	Post-dose at day 1 to day 4.

Secondary Outcome Measures

Name	Time	Method
Time to maximum plasma concentration (Tmax)	Post-dose at day 1 to day 4.
Terminal half-life (t1/2)	Post-dose at day 1 to day 4.
Apparent clearance (CL/F)	Post-dose at day 1 to day 4.
Adverse events (AEs)	Screening period up to Day 7.
Apparent volume of distribution (Vz/F)	Post-dose at day 1 to day 4.

Trial Locations

Locations (1)

Henan Provincial Infectious Disease Hospital; 🇨🇳 Zhengzhou, Henan, China