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Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment

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

NCT07152288•Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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);
•4. Normal or abnormal physical examination, 12-ECG, vital signs, chest frontal and lateral radiographs/CT, abdominal ultrasound, and laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, etc.) in the screening and baseline periods were not clinically significant.
•5. The demographic means of subjects in the normal liver function group (Group C) at screening must meet the following matching criteria:
•1. BMI matched to the hepatic impairment group (Group A + Group B) with a mean value ± 15%;
•2. Age-matched to the hepatic impairment group (Group A + Group B), mean ± 10 years;
•3. Sex-matched to liver impairment group (Group A + Group B), mean value ± 1 case;
•6. Glomerular filtration rate (eGFR) ≥75 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaborative Study Group (CKD-EPI) formula;
•7. Subjects with childbearing potential must agree to have no plans for childbearing and voluntarily use highly effective contraception with their partner from the time of signing the ICF until 1 month after administration of the test drug, and to avoid sperm/egg donation. Female subjects of childbearing potential must have a negative serum pregnancy test at both screening and baseline and not be breastfeeding.
+2 more criteria

Exclusion Criteria

•1. Smoked an average of more than 5 cigarettes per day in the past 3 months or those who cannot comply with the prohibition of smoking during the trial;
•2. Known or suspected (as judged by the researcher) immunodeficiency diseases or hereditary complement deficiencies;
•3. Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components;
•4. Screen those who have a history of heavy drinking in the past 3 months (with an average daily alcohol consumption of \> 2 units of alcohol (1 unit = 285 mL of beer, or 30 mL of spirits, or 100 mL of wine)) or those with a positive breath alcohol test;
•5. Disease or medical condition that, in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, and excretion of the drug or that may reduce compliance;
•6. History of capsular bacterial infection in the past; including but not limited to Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae type b, etc;
•7. Severe trauma or undergone surgery within 2 weeks prior to screening, or plan to undergo surgery during the trial period;
•8. Participated in a clinical trial of any other drug or medical device within 3 months prior to screening or plan to do so during the study period, or still within 5 half-lives of the drug prior to screening (whichever is longer);
•9. A previous diagnosis of malignant tumors (excluding radically resected basal cell carcinoma of the skin, papillary thyroid carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix);
•10. History of drug or substance abuse; or a positive urine drug test at screening;
+11 more criteria

Locations (1)

Peking University First Hospital

Beijing, China

Key Dates

Start Date

May 29, 2025

Primary Completion Date

September 1, 2025

Completion Date

November 1, 2025

Last Updated

September 3, 2025

Enrollment

ESTIMATED participants

Conditions

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Interventions

HSK39297 tablets

DRUG

HSK39297 tablets

DRUG

HSK39297 tablets

DRUG

Contacts

Chen Meixia

CONTACT

028-67258779 chenmeixia@haisco.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment

Inclusion Criteria

Exclusion Criteria

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