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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00823862

Enrollment

Registered

2009-01-16

Start date

2008-10-31

Completion date

2010-02-28

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

HCV, Immunostimulatory sequence (ISS), TLR9 (toll-like receptor 9), interferon (IFN), ribavirin

Brief summary

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.

Interventions

DRUGSD-101

Intramuscular (IM)

DRUGribavirin

oral, 2 times per day, for 2 months

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Adverse event timing, duration, and severity.	Between doses and up to 3 months after last dose

Secondary

Measure	Time frame
Biomarker analysis of blood sample	pre and 24 hour post dose
Viral load in blood sample	each visit

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026