The Phase I clinical trial is a randomized, double-blind, placebo-controlled trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-1625 after single and multiple ascending oral doses in healthy volunteers, and oral ascending repeat doses in subjects with hepatitis C infection.
The trial will take place in Europe and is designed to enroll 54 subjects including both healthy volunteers and HCV-infected patients. Data from the trial are anticipated to be announced later in 2009.
ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion.
Elizabeth Olek, vice president and chief medical officer of Achillion, said: "This first-in-human clinical trial will be instrumental in establishing the safety profile of ACH-1625 in humans. Importantly, it will also provide Achillion with preliminary efficacy data and important dose selection information for subsequent Phase II trials.
"We believe ACH-1625 has the potential to offer a convenient dosing schedule and an improved safety and tolerability profile compared to currently available treatments for HCV-infected patients."
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