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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group A

Subjects with mild hepatic impairment.

Group Type EXPERIMENTAL

HRS-7535 Tables

Intervention Type DRUG

Oral HRS-7535 tables.

Treatment group B

Subjects with moderate hepatic impairment.

Group Type EXPERIMENTAL

HRS-7535 Tables

Intervention Type DRUG

Oral HRS-7535 tables.

Treatment group C

Subjects with normal hepatic function.

Group Type EXPERIMENTAL

HRS-7535 Tables

Intervention Type DRUG

Oral HRS-7535 tables.

Interventions

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HRS-7535 Tables

Oral HRS-7535 tables.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes