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news.Ardea Biosciences has announced that the Medicines and Healthcare products Regulatory Agency in the UK has authorized a Phase I study evaluating RDEA594 in normal healthy volunteers. RDEA594 is the company's lead product candidate for the treatment of gout.
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This Phase I, randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability, pharmacokinetics and uric acid lowering effects of single ascending oral doses of RDEA594 in healthy adult male volunteers.
Barry Quart, president and CEO of Ardea, said: “Regulatory clearance for us to proceed with our Phase I study of RDEA594, within six months from designation as a clinical candidate, is a testament to the efficiency of our development organization, and the importance we place on our gout program – a program we intend to expand with second-generation compounds from our exciting ongoing research in this area.”