Overview
Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study
Eligibility
Inclusion Criteria:
All subjects:
- Signing the informed consent forms
- 18 years to 65 years (inclusive)
- Body mass index should be between 18 and 30 kg/m2 (inclusive)
- No medication was used before screeningor stable medication for 4 weeks.
Normal liver function
- Clinical laboratory tests during the screening period were normalor the abnormality has no clinical significance.
Hepatic impaired subjects:
- Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.
- Liver damage due to primary liver disease.
Exclusion Criteria:
All subjects:
- Subject known or suspected of being sensitive to the study drugs or its ingredient
Normal liver function
- Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.
- Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.
Hepatic impaired subjects:
- Suspected or diagnosed as liver cancer or with other malignant tumors;
- Drug induced liver injuryacute liver injuryliver transplantation history.
- Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.