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Tests treatment safety and results for Paroxysmal Nocturnal Hemoglobinuria (PNH)
Official title Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment
ClinicalTrials.gov ID: NCT07152288
What this study is testing
What is HSK39297 tablets?
HSK39297 tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for paroxysmal nocturnal hemoglobinuria (pnh).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol...
- 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 people weighing no less than 50 kg and female people weighing no less than 45 kg; body mass index (BMI): 18\~32 kg/m2...
- Normal or abnormal physical examination, 12-ECG, vital signs, chest frontal and lateral radiographs/CT, abdominal ultrasound, and laboratory tests...
- The demographic means of people in the normal liver function group (Group C) at screening must meet the following matching criteria:
You likely can't join 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 =...
- Disease or medical condition that, in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, and excretion of...
- History of capsular bacterial infection in the past; including but not limited to Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus...
See the full eligibility criteria
Who can join
- 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 people weighing no less than 50 kg and female people 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...
- The demographic means of people 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;
- people 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- Any physical or psychological disease or condition that, in the judgment of the investigator, is likely to increase the risk of the trial, interfere with compliance with the protocol and ability to complete the trial...
- History of any serious disease other than the primary disease of the liver itself, or a history of and/or abnormal clinically significant clinical laboratory tests that, in the opinion of the investigator, may affect...
- Liver failure, or cirrhosis with combination of hepatic encephalopathy (West-Haven Level 2 and above), hepatocellular carcinoma (except for those with Barcelona Clinic Liver Cancer (BCLC) stage 0 or those who have...
- On systemic hormones (except people on stable use of ≤ 5 mg/day of prednisone or equivalent doses of glucocorticoids) or other immunosuppressive agents within 4 weeks prior to screening, or more than 4 weeks from their...
- Alpha-fetoprotein \> 20 ng/mL; hemoglobin (Hb) ≤ 70 g/L; alanine aminotransferase (ALT) or mentholatum aminotransferase (AST) ≥ 5 times the upper limit of normal (ULN); severe active bleeding or a platelet level...
- History of liver transplantation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.