Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepati… (NCT06674915) | Clinical Trial Compass
CompletedPhase 1
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment
China24 participantsStarted 2024-11-26
Plain-language summary
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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);
✓. 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.
✓. The demographic means of subjects in the normal liver function group (Group C) at screening must meet the following matching criteria:
✓. Weight matched to the hepatic impairment group (Group A + Group B) with a mean value ± 10 kg;
Exclusion criteria
✕. Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components;
✕. 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;
✕. Prior history of meningococcal infection or a first-degree relative with a history of meningococcal infection;
✕. Existing or suspected infection (at the investigator's discretion) within 2 weeks prior to screening, or fever;
✕. Severe trauma or undergone surgery within 8 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);
✕. Smoked an average of more than 5 cigarettes per day in the 4 weeks, or consumed an average of more than 15 g of alcohol in a day in the 4 weeks prior to screening (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-potency liquor), or a positive breath alcohol test at baseline;
✕. History of drug or substance abuse; or a positive urine drug test at screening;