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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: IMO-2125
* Drug: Saline placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMO-2125 0.04 mg/kg q week<br>IMO-2125 given weekly at 0.04 mg/kg | Drug: IMO-2125<br>* 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<br>|
| Experimental: IMO-2125 0.08 mg/kg q week<br>IMO-2125 given weekly at 0.08 mg/kg | Drug: IMO-2125<br>* 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<br>|
| Experimental: IMO-2125 0.16 mg/kg q week<br>IMO-2125 given weekly at 0.16 mg/kg | Drug: IMO-2125<br>* 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<br>|
| Experimental: IMO-2125 0.32 mg/kg q week<br>IMO-2125 given weekly at 0.32 mg/kg | Drug: IMO-2125<br>* 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<br>|
| Experimental: IMO-2125 0.48 mg/kg q week<br>IMO-2125 given weekly at 0.48 mg/kg | Drug: IMO-2125<br>* 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<br>|
| Placebo Comparator: Placebo<br>Weekly saline placebo | Drug: Saline placebo<br>* saline placebo given subcutaneously<br>|
| Experimental: IMO-2125 0.16 mg/kg twice a week<br>IMO-2125 given twice a week at 0.16 mg/kg | Drug: IMO-2125<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Safety. | Count and percentage of subjects with treatment emergent adverse events | From screening through study completion, 86 to 115 days in total | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, unresponsive to pegylated interferon and ribavirin therapy, hepatitis C virus