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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dynavax Technologies Corporation
• Collaborators: PPD; Synteract, Inc.
• Treatments: Ribavirin

Criteria

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.