Actively Recruiting
A Single-dose, Open-label, Phase I Study Comparing the Pharmacokinetics, Safety, and Pharmacodynamics of HSK39297 in Subjects With Mild and Moderate Hepatic Impairment and Normal Hepatic Function
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2025-09-03
24
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics, safety, and pharmacodynamics of the drug HSK39297 in adults aged 18 to 70 years with mild to moderate liver impairment compared to those with normal liver function. This Phase 1, open-label study aims to better understand how the drug behaves in different liver health conditions to inform future use. The study is sponsored by Haisco Pharmaceutical Group Co., Ltd. Participants will receive a single oral dose of HSK39297 and be assigned to one of three groups: mild hepatic impairment, moderate hepatic impairment, or normal liver function. The study monitors drug concentration over 10 days post-dose and includes groups matched by age, sex, and body mass index to ensure comparability. Subjects with liver impairment must meet specific criteria including stable medication use and Child-Pugh classification. During the study, participants will undergo physical exams, vital sign checks, ECGs, imaging, and laboratory tests before and after dosing. Researchers will measure drug levels including peak concentration (Cmax), area under the curve (AUC), and other pharmacokinetic parameters from day 1 to day 10. Safety will be monitored by recording adverse events throughout the screening and follow-up periods. The total commitment covers screening and 10 days post-dose observation.
CONDITIONS
Brief 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 study procedures, participate voluntarily, and complete the study per protocol
- Aged 18 to 70 years at consent, male or female
- Males weigh at least 50 kg; females weigh at least 45 kg; BMI between 18 and 32 kg/m2
- No clinically significant abnormalities in physical exam, ECG, vital signs, chest imaging, abdominal ultrasound, and lab tests at screening
- Normal liver function group must be matched by BMI, age, and sex to hepatic impairment groups
- Estimated glomerular filtration rate (eGFR) of at least 75 mL/min/1.73m2
- Females of childbearing potential must use effective contraception and have negative pregnancy tests at screening and baseline; not breastfeeding
- For hepatic impairment groups: stable medication for at least 4 weeks or no medication in prior 4 weeks
- Child-Pugh Class A or B liver impairment without albumin use within 14 days
You will not qualify if you...
- Smoking more than 5 cigarettes per day in 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 study drug
- History of heavy drinking in past 3 months or positive breath alcohol test
- Medical conditions interfering with drug processing or study compliance
- History of capsular bacterial infections
- Recent severe trauma or surgery within 2 weeks, or planned surgery during study
- Participation in other clinical trials within 3 months or within 5 half-lives of other drugs
- Prior malignant tumors except certain skin and cervical cancers
- History of drug or substance abuse or positive urine drug test
- Recent blood donation or transfusion
- Abnormal ECG values or unsuitable ECG findings
- Difficulty swallowing or blood collection or unable to complete follow-up
- Vaccination within 2 weeks prior to dosing or planned during study
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis antibody (except in liver impairment group)
- Physical or psychological conditions increasing risk or reducing compliance
- For hepatic impairment: serious diseases beyond liver condition, liver failure, cirrhosis with encephalopathy, hepatocellular carcinoma except certain stages, bleeding complications
- Recent use of systemic hormones or immunosuppressants beyond allowed limits
- Abnormal lab values including alpha-fetoprotein, hemoglobin, liver enzymes, platelets
- History of liver transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive a single oral dose of HSK39297 tablets and are monitored for pharmacokinetics, safety, and pharmacodynamics.
Daily visits from day 1 to day 10
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
C
Chen Meixia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here