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news.Inhibitex has announced that its investigational new drug application for FV-100, the company's oral nucleoside analogue in development for the treatment of shingles, has been accepted by the FDA.
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The company has enrolled the first cohort (100mg) in a Phase I clinical trial that will evaluate the safety and pharmacokinetics of up to four single ascending doses of FV-100 in healthy subjects. Each dose cohort will include six subjects who will receive FV-100 and two subjects who will receive placebo.
Russell Plumb, CEO and president of Inhibitex, said: “We plan to conduct a multiple ascending dose study of FV-100 in the third quarter and initiate a Phase II trial of FV-100 around the end of 2008.”