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

Idera Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: Saline placebo; Drug: IMO-2125

Study type: Interventional

Funder types: Industry

Identifiers

NCT00728936

IMO-2125-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 7 patient groups, including a placebo group

IMO-2125 0.04 mg/kg q week

Experimental group

Description:

IMO-2125 given weekly at 0.04 mg/kg

Treatment:

Drug: IMO-2125

IMO-2125 0.08 mg/kg q week

Experimental group

Description:

IMO-2125 given weekly at 0.08 mg/kg

Treatment:

Drug: IMO-2125

IMO-2125 0.16 mg/kg q week

Experimental group

Description:

IMO-2125 given weekly at 0.16 mg/kg

Treatment:

Drug: IMO-2125

IMO-2125 0.32 mg/kg q week

Experimental group

Description:

IMO-2125 given weekly at 0.32 mg/kg

Treatment:

Drug: IMO-2125

IMO-2125 0.48 mg/kg q week

Experimental group

Description:

IMO-2125 given weekly at 0.48 mg/kg

Treatment:

Drug: IMO-2125

Placebo

Placebo Comparator group

Description:

Weekly saline placebo

Treatment:

Drug: Saline placebo

IMO-2125 0.16 mg/kg twice a week

Experimental group

Description:

IMO-2125 given twice a week at 0.16 mg/kg

Treatment:

Drug: IMO-2125