Study To Evaluate The Pharmacokinetics Of Jaktinib Hydrochloride Tablets In Subjects With Hepatic Impairment And Normal Hepatic Function

ZGJAK021

This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to healthy matched control subjects with normal hepatic function(matched by age, weight, and sex).

2021-08-27

2022-09-19

2022-09-19

Completed

Early phase I

24

Inclusion Criteria: * Able to comprehend and willing to sign an informed consent form. Ability to comply with trial and follow-up procedures. * Age 18-79 years at the time of signing the ICF, either male or female. * Male subjects body weight at least 50 kg, and female subjects body weight at least 45 kg. Body mass index (BMI) between 18 and 32 kg/m2 to participate. * After physical examination, vital signs, laboratory examinations, 12-lead electrocardiogram examination, the investigator determined that it is suitable to participate in this study. * Subjects are willing to take effective contraceptive measures from screening to 3 months after administration. Additional Inclusion Criteria for Hepatic Impaired Subjects Only: * Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment(Requires no use of albumin within 14 days), And it is dysfunction caused by previous primary liver disease. * Any examination such as B-ultrasound, CT, MRI, FibroScan or liver biopsy confirms the presence of cirrhosis. Additional Inclusion Criteria for Healthy Subjects Only: * Have not taken any medicine within 2 weeks before administration; or have stable medication for at least 4 weeks before administration for the treatment of other comorbid diseases. Exclusion Criteria: * Drug-induced liver injury. * Acute liver damage caused by various reasons. * Patients with liver failure, or combined with dominant hepatic encephalopathy, liver cancer, etc., which the investigator believes are not suitable for participating in the study. * Patients with a history of massive bleeding from esophageal varices without band ligation, sclerosing agent and TIPS treatment * Subjects with suspected allergies to Jaktinib or its excipient. * History of blood donation of 400 mL or more of blood within 3 months prior to screening. * Drug dependency, a positive urine drug screen. * Subjects with any significant clinical and laboratory abnormalities which may affect the safety evaluation. * Subjects suffering from arrhythmia and requiring treatment, or QTcB \> 480ms at screening. * Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening. * Subjects with known human immunodeficiency virus (HIV), * Subjects with epilepsy or patients who have received psychotropic drug or sedatives during screening. * Subjects who had experienced malignant tumors within the past 5 years (except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ that have been cured). * Subjects who have participated in another clinical trial of a new drug or medical instrument within 3 months before screening. * Females who are breastfeeding or pregnant at Screening. Exclusion Criteria for Healthy Subjects Only: * Subjects with hepatitis B surface antigen positive or HCV-RNA positive. * Patients with a history of liver dysfunction, or physical examination and laboratory examination at screening indicate that there is or may have liver dysfunction.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2024-01-11