Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Criteria

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.