A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
brief summary
This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects with genotype 1 hepatitis C.
detailed description
The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV).
The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with ribavirin(RBV). The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with ribavirin(RBV).
official title
A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of Subcutaneous Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C