The single ascending dose study is being conducted in the US under an exploratory investigational new drug application and will evaluate the safety and pharmacokinetics of three doses of drug in 24 healthy volunteers.
Published in vitro studies demonstrate that orally bioavailable nucleoside analogue (FV-100) is the most potent and fastest acting antiviral compound discovered to date for the treatment of shingles. Inhibitex believes these characteristics provide the potential for FV-100 to be dosed once-a-day and to significantly reduce shingles-related symptoms, including the incidence and the severity of post-herpetic neuralgia, as compared to currently used antiviral therapeutics.
Russell Plumb, president and CEO of Inhibitex, said: “We are delighted with the speed in which we have been able to move FV-100 into this first-in-man trial, which reflects our commitment to advancing the development of our emerging antiviral pipeline. We anticipate that top line data from this trial will be available around year end.”