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

NCT06961643 | Completed Phase 1

• 1 other identifier: HRS-7535-109
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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 the last quantifiable concentration (AUC0-t)

  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.

Secondary Outcomes (5)

• 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.

• Apparent volume of distribution (Vz/F)

  Post-dose at day 1 to day 4.

• Adverse events (AEs)

  Screening period up to Day 7.

Study Arms (3)

Treatment group A

EXPERIMENTAL

Subjects with mild hepatic impairment.

Drug: HRS-7535 Tables

Treatment group B

EXPERIMENTAL

Subjects with moderate hepatic impairment.

Drug: HRS-7535 Tables

Treatment group C

EXPERIMENTAL

Subjects with normal hepatic function.

Drug: HRS-7535 Tables

Interventions

HRS-7535 Tables DRUG

Oral HRS-7535 tables.

Treatment group A; Treatment group B; Treatment group C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female.
• 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).

You may not qualify if:

• In the judgment of the investigator, may be allergic to the study drug or its components.
• Smoking an average of more than 10 cigarettes per day within 3 months prior to screening.
• 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.
• History of drug or substance abuse, or a positive urine drug test at screening.
• Donated or lost ≥ 400 mL of blood within 3 months prior to screening.
• Individuals with a history of severe hypoglycemia.
• Undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Henan Provincial Infectious Disease Hospital

Zhengzhou, Henan, 450015, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 8, 2025
• Study Start: June 5, 2025
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

CN (1)