NCT00728936

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Idera Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-12-01
• Completion: 2010-05-01
• First posted: 2008-08-06
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

7 sites across 2 countries: United States, Puerto Rico