Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients

A Phase 1, Multi-center, Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 in Hepatitis C-infected Patients Unresponsive to Standard Treatment With Pegylated Interferon and Ribavirin

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.

Inclusion Criteria:

• HCV-positive
• Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin

Exclusion Criteria:

• Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)
• Inadequate bone marrow, liver, and renal function
• Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days
• Other significant medical diseases
• Known alcohol or drug abuse within the past 12 months