Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of SH229 in Patients With HCV Infection

Exclusion Criteria

• •Smoke more than 5 cigarettes per day within three months prior to screening;
• •Subjects allergic to the study drug (including its excipients) or subjects who are prone to allergies;
• •History of drug and/or alcohol abuse (alcohol consumption exceeding 14 units per week: 1 unit = 285 mL of beer, or 25 mL of hard liquor, or 100 mL of wine);
• •Blood donation or massive blood loss (\> 450 mL) within three months prior to screening;
• •History of any non-HCV liver diseases, including but not limited to hemochromatosis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non-alcoholic steatohepatitis, etc.;
• •Subjects with dysphagia or with any gastrointestinal disorders (or postoperative conditions) that may affect the study drug absorption;
• •Subjects with any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
• •Use of any drugs that alter liver enzyme activity within 28 days prior to screening;
• •Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 14 days prior to screening;
• •Use of special diet (including dragon fruit, mango, grapefruit, etc.), strenuous activities or other factors that may affect the disposition of the study drug within 2 weeks prior to screening;
• •Concomitant use of strong inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone;
• •Subjects with major changes in diet or exercise habits recently;
• •Participation in other clinical trials within three months prior to enrollment;
• •Electrocardiogram abnormalities with clinical significance;
• •Laboratory tests with clinical significance or other clinical findings that indicate clinically significant diseases not associated with HCV infection (including but not limited to gastrointestinal, renal, hepatic, neurologic, hematological, endocrine, pulmonary, psychiatric, cardiovascular diseases);
• •Pregnant or lactating women;
• •Creatinine clearance ≤ 60 mL/min;
• •Evidence of co-infection with HBV, HIV, or syphilis;
• •Child-Pugh Grade B or C;
• •Clinically significant hepatic decompensation including but not limited to, hepatic encephalopathy, hepatocellular carcinoma, variceal bleeding, ascites, etc.;
• •Use of chocolate, food or beverages containing caffeine or xanthine within 24 hours prior to dosing;
• •Use of products containing alcohol within 24 hours prior to dosing;
• •Subjects with urine drug screening test positive, or with history of drug abuse in the past 5 years;