Evaluate the Efficacy and Safety of TG-2349 in Subjects With Hepatitis C Infection

Inclusion Criteria

• Willing and able to provide written informed consent.
• East Asian subjects, male or female, and age between 18 (or legal adult age) and 70 years, inclusive, at Baseline/Day 1.
• Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 (inclusive) and body weight ≥ 40 kg.
• Presence of chronic hepatitis C (CHC) as documented below:

(1) A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit or (2) A liver biopsy or FibroTest performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection, such as the presence of fibrosis and/or inflammation.

• Positive for anti-HCV antibody at Screening. 6. Presence of an HCV RNA level ≥ 1 x 10000 IU/mL at Screening as determined by the Central Laboratory.
• Presence of genotype 1b HCV-infection at Screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation.
• HCV treatment naïve defined as no prior therapy with any interferon (IFN), ribavirin (RBV), or other approved or investigational HCV-specific agent.
• Absence of cirrhosis

Cirrhosis as defined as any one of the following:

• Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score ≥ 5).
• FibroScan showing cirrhosis or results > 12.5 kPa.
• FibroTest fibrosis score of > 0.58 and APRI (AST: platelet ratio index) of > 2 during Screening.

If no definitive diagnosis of cirrhosis by the above criteria, a liver biopsy is required; liver biopsy results will supersede non-invasive testing results and be considered definitive.

• Screening ECG without clinically significant abnormalities. 11. Subjects must have the following laboratory parameters at Screening:
• ALT ≤ 10 × the upper limit of normal (ULN)
• AST ≤ 10 × ULN
• Total bilirubin ≤ 1.5 × ULN except history of Gilbert's syndrome. If Gilbert's syndrome is the proposed etiology, the total bilirubin must ≤ 2 × ULN.
• Absolute neutrophil count (ANC) ≥ 1, 500 cells/mm3
• Platelet count ≥ 90,000 cells/mm3
• HbA1c ≤ 8.5%
• Thyroid stimulating hormone (TSH) and free T4 ≤ ULN
• Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation
• Serum creatinine ≤ 1.5 × ULN
• Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects
• Albumin ≥ 3.5 g/dL
• INR (International Normalized Ratio for Prothrombin Time) ≤ 1.5 x ULN unless subject is stable on an anticoagulant regimen affecting INR
• Anti-nuclear antibodies (ANA) ≤ 1: 320. 12. Subject must be of generally good health, with the exception of chronic HCV infection, as determined by Investigator.
• Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments, including all required Post-Treatment visits.
• A female subject is eligible to enter the study if it is confirmed that she is:

(1) Not pregnant or nursing. (2) Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal - women > 50 years of age with cessation (for ≥12 months) of previously occurring menses), or (3) Of childbearing potential (i.e., women who have not had a hysterectomy, have not had both ovaries removed, and have not had medically documented ovarian failure).

Women ≤ 50 years of age with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from Screening until 6 months after the last dose of study drug(s):

• Complete abstinence from intercourse. Periodic abstinence from intercourse (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.

Or - Consistent and correct use of 1 of