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

NCT00728936 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-02-15

Study results available
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Summary

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

Conditions

  • Hepatitis C

Interventions

DRUG

IMO-2125

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

DRUG

Saline placebo

saline placebo given subcutaneously

Sponsors & Collaborators

  • Idera Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Alice Bexon, MD · Idera Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-12-31
Completion
2010-05-31

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00728936 on ClinicalTrials.gov