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

Idera Pharmaceuticals, Inc.58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hepatitis C

Interventions

IMO-2125DRUG

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

Saline placeboDRUG

saline placebo given subcutaneously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (7)

University of Colorado Hospital

Aurora, Colorado, United States

Gastoenterstinal Specialist of Georgia, PA

Marietta, Georgia, United States

Henry Ford Med Ctr- Columbus

Novi, Michigan, United States

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Evaluation of Safety.

Count and percentage of subjects with treatment emergent adverse events

Time frame: From screening through study completion, 86 to 115 days in total

Data from ClinicalTrials.gov

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