Safety and Efficacy Study of Single Doses of TT-034 in Patients With Chronic Hepatitis C

Exclusion Criteria

• •Body mass index \< 18.5 or \> 30
• •Total body weight \> 80 KG
• •Female subjects of childbearing potential (including females with tubal ligation) or women who are pregnant or nursing
• •Male subjects who are unwilling to provide the required semen samples
• •Presence of nAb levels to AAV8 that abrogate AAV8 transduction
• •Severe Liver disease
• •Hepatocellular carcinoma (HCC) or suspicion of HCC
• •Coronary artery disease
• •Platelet count of \< 150 x 109/L or Creatinine ≥ 1.5 mg/dL at Screening
• •Hypertension with systolic blood pressure consistently ≥ 130 mmHg or diastolic blood pressure consistently ≥ 90 mmHg
• •Screening examinations indicative of possible occult malignancy unless cancer has been excluded
• •Family history of colon cancer in any first-degree relative unless ruled out by colonoscopy
• •Positive for human immunodeficiency virus 1 (HIV1) or HIV2 antibody
• •Co-infection with hepatitis B virus
• •History of autoimmune disease
• •Renal impairment
• •Hospitalization for liver disease within 60 days of Screening
• •Use of drugs of abuse in the prior 3 months
• •Other concomitant disease or condition likely to significantly decrease life expectancy or cancer
• •Treatment with an investigational drug within 6 months preceding the first dose of trial medication
• •Received an AAV vector previously or any other gene transfer agent in the previous 6 months
• •History of cardiac abnormalities, as assessed at the Screening Visit
• •Twelve-lead ECG demonstrating QTcB \> 465 ms at Screening
• •Chronic hepatic diseases
• •Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurologic, or allergic diseases.
• •Evidence of autoimmune disease or pre-existing autoimmune or antibody-mediated diseases
• •Use of immunosuppressive medications within 6 months before the entry into this study, except for inhaled or topical corticosteroids