The double-blind, placebo-controlled single ascending dose (SAD) trial evaluated the safety and pharmacokinetics of four doses of FV-100 in five cohorts of healthy volunteers (100, 200, 400, and 800mg, as well as a 400mg food effect group).
Each cohort consisted of six subjects that received FV-100 and two that received placebo. The company reported that there were no serious adverse events observed and the compound appeared to be generally well tolerated in the trial.
In addition, pharmacokinetic data demonstrated that all doses evaluated in the trial maintained drug plasma levels of the active form of FV-100 that exceeded its EC50 for at least 24 hours. The EC50 represents the concentration of a drug that is required for 50% inhibition of viral replication in vitro.
The recently initiated multiple ascending dose (MAD) trial in healthy subjects is designed to evaluate the safety and pharmacokinetics of five oral doses of FV-100 (100, 200, 400 and 800mg administered once daily and 200mg administered twice daily, each for seven days).
Similar to the SAD trial, each dose cohort will consist of six subjects that will receive FV-100 and two that will receive placebo. The company anticipates completing the MAD trial in the fourth quarter of 2008.
Russell Plumb, president and CEO of Inhibitex, said: “Subject to the results of the multiple ascending dose trial, we plan to advance FV-100 into a well powered, proof of concept Phase II clinical trial around the end of 2008 to evaluate both once- and twice-daily doses in shingles patients.”