A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV).

The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with ribavirin(RBV). The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with ribavirin(RBV).

Inclusion criteria

• Diagnosis of chronic hepatitis C genotype 1a or 1b
• Male or female aged 18 to 65 years, inclusive
• Compensated liver disease without evidence of cirrhosis
• No evidence of type 1 or 2 diabetes mellitus, lipodystrophy or polycystic ovary syndrome
• No history or presence of autoimmune or lymphoproliferative disease or hemoglobinopathies
• Stable medication doses for 1 month for the chronic disease if subjects have chronic diseases, including but not limited to hypertension and dyslipidemia

Exclusion criteria

• History of previous treatment of hepatitis C
• Currently use medication for psychiatric illness including depression, suicidal ideation, and psychosis
• History or presence of chronic liver disease
• History of drug or alcohol abuse within the past year
• Evidence of active illicit drug use
• Clinically significant abnormal electrocardiogram (ECG) or rhythm strip
• Female subject who has a positive urine pregnancy test or who is lactating