The objectives of this trial are to assess safety, tolerability, and pharmacokinetics following ascending single oral doses of ANA598 in healthy volunteers. Approximately 40 healthy subjects will participate in the study, which is being conducted in the US.
Following successful completion of the healthy volunteer study, Anadys plans to begin a Phase Ib study of ANA598 in hepatitis C virus (HCV)-infected patients in the third quarter of 2008.
ANA598 is a highly potent and selective inhibitor of HCV genotypes 1a and 1b NS5b RNA polymerases and of HCV replication in cell culture.
James Freddo, chief medical officer of Anadys, said: “We are excited about initiating this clinical program and look forward to future trials of ANA598 in HCV patients, first as a single agent and then in subsequent combination studies. We expect the full benefit of direct antivirals to be demonstrated when studied as components of novel combination regimens incorporating multiple anti-HCV agents.”