Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose Study in Healthy Volunteers and Patients With Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANA773 Tosylate

The overall study design includes two parts, Part A and Part B.

Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study.

Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.

Study Design:

Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study.

Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.

Part A Inclusion:

• Male or female, ages 18 to 65 years
• No clinically significant abnormalities
• No serious or severe chronic conditions
• Non-smokers

Part A Exclusion:

• Female subjects who are pregnant or breast-feeding
• History of significant medical condition that could interfere with study medication or associated study assessments
• History of or current drug or alcohol abuse

Part B Inclusion Criteria:

• Male or female, ages 18 to 65 years
• Diagnosed with chronic liver disease consistent with chronic hepatitis C infection for at least 6 months
• Screening HCV RNA ≥ 375,000 copies/mL or ≥ 75,000 IU/mL
• Naïve to or have relapsed from prior IFN-alpha based therapy

Part B Exclusion Criteria:

• Female subjects who are pregnant or breast-feeding
• Received anti-viral therapy or immunomodulatory therapy within 90 days prior to administration of the first dose of study medication
• Use of an investigational drug or participation in an investigational study with a licensed drug within 30 days
• History of significant medical condition that could interfere with study medication or associated study assessments
• History of or current drug or alcohol abuse