Actively Recruiting
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2025-09-03
24
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HSK39297 in subjects with mild to moderate hepatic impairment and normal hepatic function
CONDITIONS
Official Title
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily participate in the study and sign informed consent
- Aged 18 to 70 years old
- Male subjects weigh at least 50 kg; female subjects weigh at least 45 kg
- Body mass index between 18 and 32 kg/m2
- Normal or clinically acceptable physical exam, ECG, chest X-ray/CT, abdominal ultrasound, and lab tests at screening
- For the normal liver function group, matched to hepatic impairment groups by BMI (±15%), age (±10 years), and sex (±1 case)
- Estimated glomerular filtration rate (eGFR) of at least 75 mL/min/1.73m2
- For subjects with childbearing potential: agree to use effective contraception from signing consent until 1 month after dosing, have negative pregnancy tests at screening and baseline, and not breastfeed
- For hepatic impairment subjects: no medication changes within 4 weeks before screening or stable medication for at least 4 weeks
- Child-Pugh Class A or B liver impairment without albumin use within 14 days
- Liver impairment caused by chronic liver diseases such as non-alcoholic steatohepatitis or viral hepatitis
You will not qualify if you...
- Smoked more than 5 cigarettes per day in the past 3 months or unable to stop smoking during the trial
- Known or suspected immunodeficiency or hereditary complement deficiencies
- Allergic to two or more allergens or potentially allergic to the study drug
- History of heavy alcohol use in past 3 months or positive breath alcohol test
- Conditions that may affect drug absorption, metabolism, or compliance
- History of serious bacterial infections such as Neisseria meningitidis or Streptococcus pneumoniae
- Severe trauma or surgery within 2 weeks before screening or planned surgery during study
- Participated in other clinical trials within 3 months or within 5 half-lives of another drug
- History of malignant tumors except certain skin and thyroid cancers
- History of drug or substance abuse or positive drug test at screening
- Blood donation or transfusion within 30 days before screening
- QTcF > 480 ms or significant ECG abnormalities
- Difficulty swallowing or tolerating blood draws or unable to complete follow-up
- Vaccination within 2 weeks prior to dosing or planned vaccination during study
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis antibody (except hepatitis markers in liver impairment group)
- Any physical or psychological condition increasing trial risk or affecting compliance
- Additional exclusions for hepatic impairment group including serious other diseases, liver failure or severe complications, recent immunosuppressive therapy, abnormal lab tests, and history of liver transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
C
Chen Meixia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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