Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

Study Overview
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Brief Summary
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To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.

Official Title
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A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study of SD-101 to Assess the Safety, Pharmacodynamics, and Preliminary Evidence of Anti-Viral Effect in Subjects Diagnosed With Chronic Hepatitis C, Genotype 1

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: SD-101
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed, written, informed consent Male or female subjects, 18 to 55 years of age. Subject must have chronic infection HCV, genotype 1. Serum HCV-RNA concentrations 100,000 IU/mL to 10,000,000 IU/mL No prior treatment for HCV. Must be negative for hepatitis B (HBV) and human immunodeficiency virus (HIV). Must be willing to use dual method of contraception (i.e., barrier and spermicide; birth control pills and barrier) during the study. No known hypersensitivity to study medication or to drugs chemically related to the study. Exclusion Criteria: Prior treatment with IFN-based therapies and/or anti-viral therapies. Women with ongoing pregnancy or breast feeding and male partners of women who are pregnant. Reduced kidney function. Presence of concomitant liver diseases Signs or symptoms of hepatocellular carcinoma. Thyroid disease currently poorly controlled on prescribed medications. History of hemoglobinopathy. Evidence of severe retinopathy. Other serious medical conditions, including human immunodeficiency virus, cancer (excluding non-melanoma skin cancer), or evidence of drug or alcohol abuse. Subjects with documented or presumed coronary artery disease, pulmonary disease, or cerebrovascular disease Clinically significant acute or chronic illnesses. History of severe psychiatric disease, especially depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active (SD-101)<br>SD-101 in cohorts of escalating doses | Drug: SD-101<br>* Intramuscular (IM)<br>* Other names: TLR9 Agonist;Drug: ribavirin<br>* oral, 2 times per day, for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event timing, duration, and severity. |  | Between doses and up to 3 months after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker analysis of blood sample |  | pre and 24 hour post dose | 
| Viral load in blood sample |  | each visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, Immunostimulatory sequence (ISS), TLR9 (toll-like receptor 9), interferon (IFN), ribavirin