Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects

A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected With Genotype 1 Chronic Hepatitis C

This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.

Inclusion criteria:

1. 18-65 years old
2. Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control.
3. Plasma HCV RNA ≥ 5 log10 IU/mL
4. HCV genotype 1

Exclusion criteria:

1. Received prior antiviral treatment for hepatitis C infection
2. Subject is pregnant or breastfeeding
3. Body Mass Index (BMI) > 32
4. Currently abusing alcohol or illicit drugs
5. Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction
6. Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)