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

NCT07152288 | Recruiting Phase 1

• 1 other identifier: HSK39297-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Outcome Measures

Primary Outcomes (3)

• Cmax

  The maximum plasma concentration.

  Post-dose at day 1 to day 10.

• AUC0-t

  Area under the concentration curve from time 0 to the last quantifiable concentration

  Post-dose at day 1 to day 10

• AUC0-inf

  Area under the concentration curve from time 0 to extrapolated infinite time

  Post-dose at day 1 to day 10

Secondary Outcomes (5)

• Tmax

  Post-dose at day 1 to day 10

• t1/2

  Post-dose at day 1 to day 10

• CL/F

  Post-dose at day 1 to day 10

• Vz/F

  Post-dose at day 1 to day 10

• Incidence and severity of adverse events

  Screening period up to day 10

Study Arms (3)

Treatment group A

EXPERIMENTAL

Subjects with mild hepatic impairment.

Drug: HSK39297 tablets

Treatment group B

EXPERIMENTAL

Subjects with moderate hepatic impairment.

Drug: HSK39297 tablets

Treatment group C

EXPERIMENTAL

Subjects with normal hepatic function

Drug: HSK39297 tablets

Interventions

HSK39297 tablets DRUG

oral

Treatment group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.
• The demographic means of subjects in the normal liver function group (Group C) at screening must meet the following matching criteria:
• BMI matched to the hepatic impairment group (Group A + Group B) with a mean value ± 15%;
• Age-matched to the hepatic impairment group (Group A + Group B), mean ± 10 years;
• Sex-matched to liver impairment group (Group A + Group B), mean value ± 1 case;
• Glomerular filtration rate (eGFR) ≥75 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaborative Study Group (CKD-EPI) formula;
• 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.
• Not on medication within 4 weeks prior to screening, or have at least 4 weeks of stable medication for hepatic impairment and/or other co-morbidities requiring long-term treatment;
• Child-Pugh classification of Class A or B (without the use of albumin within 14 days), which is chronic liver injury caused by previous primary liver diseases, including but not limited to non-alcoholic steatohepatitis, viral hepatitis (hepatitis B, hepatitis C), etc.

You may not qualify if:

• 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;
• Known or suspected (as judged by the researcher) immunodeficiency diseases or hereditary complement deficiencies;
• Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components;
• 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;
• 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;
• History of capsular bacterial infection in the past; including but not limited to Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae type b, etc;
• Severe trauma or undergone surgery within 2 weeks prior to screening, or plan to undergo surgery during the trial period;
• 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);
• 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);
• History of drug or substance abuse; or a positive urine drug test at screening;
• Donated or lost ≥ 400 mL of blood within 30 days, or received a blood transfusion prior to screening;
• QTcF (males) \> 480 ms at screening, or other 12-ECG abnormalities judged by the investigator to be clinically significant or unsuitable for participation;
• Difficulty in swallowing, collecting blood intravenously, or physically unable to tolerate blood collection, or not expected to complete the entire trial follow-up;
• Vaccined within 2 weeks prior to dosing or plan to receive the vaccine during the study;
• Positive result in the screening of any of the following indicators: hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis antibody (hepatitis B surface antigen and hepatitis C antibody can be positive in subjects in the liver insufficiency group).

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Central Study Contacts

Chen Meixia

CONTACT

028-67258779; chenmeixia@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: May 29, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

CN (1)