Conditions: Hepatitis C
Keywords: Hepatitis C unresponsive to pegylated interferon and ribavirin therapy hepatitis C virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 58
Healthy volunteers: no

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

Detailed description:
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.

Arms:
arm 1: IMO-2125 given weekly at 0.04 mg/kg arm 2: IMO-2125 given weekly at 0.08 mg/kg arm 3: IMO-2125 given weekly at 0.16 mg/kg arm 4: IMO-2125 given weekly at 0.32 mg/kg arm 5: IMO-2125 given weekly at 0.48 mg/kg arm 6: Weekly saline placebo arm 7: IMO-2125 given twice a week at 0.16 mg/kg

Interventions: intervention 1: IMO-2125 intervention 2: Saline placebo
Intervention descriptions: intervention 1: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system intervention 2: saline placebo given subcutaneously

Protocol document: