Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study of SD-101 to Assess the Safety, Pharmacodynamics, and Preliminary Evidence of Anti-Viral Effect in Subjects Diagnosed With Chronic Hepatitis C, Genotype 1

To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.

Inclusion Criteria:

• Signed, written, informed consent
• Male or female subjects, 18 to 55 years of age.
• Subject must have chronic infection HCV, genotype 1.
• Serum HCV-RNA concentrations 100,000 IU/mL to 10,000,000 IU/mL
• No prior treatment for HCV.
• Must be negative for hepatitis B (HBV) and human immunodeficiency virus (HIV).
• Must be willing to use dual method of contraception (i.e., barrier and spermicide; birth control pills and barrier) during the study.
• No known hypersensitivity to study medication or to drugs chemically related to the study.

Exclusion Criteria:

• Prior treatment with IFN-based therapies and/or anti-viral therapies.
• Women with ongoing pregnancy or breast feeding and male partners of women who are pregnant.
• Reduced kidney function.
• Presence of concomitant liver diseases
• Signs or symptoms of hepatocellular carcinoma.
• Thyroid disease currently poorly controlled on prescribed medications.
• History of hemoglobinopathy.
• Evidence of severe retinopathy.
• Other serious medical conditions, including human immunodeficiency virus, cancer (excluding non-melanoma skin cancer), or evidence of drug or alcohol abuse.
• Subjects with documented or presumed coronary artery disease, pulmonary disease, or cerebrovascular disease
• Clinically significant acute or chronic illnesses.
• History of severe psychiatric disease, especially depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease.