CompletedPhase 1

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

China24 participantsStarted 2025-06-05

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

The maximum plasma concentration of HRS-7535 (Cmax)

Timeframe: Post-dose at day 1 to day 4.

Area under the concentration curve from time 0 to the last quantifiable concentration (AUC0-t)

Timeframe: Post-dose at day 1 to day 4.

Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)

Timeframe: Post-dose at day 1 to day 4.

Trial details

NCT IDNCT06961643

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-22

View on ClinicalTrials.gov More Diabetes Mellitus trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

The maximum plasma concentration of HRS-7535 (Cmax)

Timeframe: Post-dose at day 1 to day 4.

Area under the concentration curve from time 0 to the last quantifiable concentration (AUC0-t)

Timeframe: Post-dose at day 1 to day 4.

Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)

Timeframe: Post-dose at day 1 to day 4.