Status:
RECRUITING
Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function
Lead Sponsor:
Shandong Suncadia Medicine Co., Ltd.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06961643
Start Date
June 5 2025
End Date
April 1 2026
Last Update
June 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Henan Provincial Infectious Disease Hospital
Zhengzhou, Henan, China, 450015