Ardea gets go-ahead for Ph I RDEA594 UK trial
The USA's Ardea Biosciences says that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has authorized a Phase I study evaluating RDEA594 in normal healthy volunteers. The agent is the company's lead product candidate for the treatment of gout.
Ardea chief executive Barry Quart said: "earlier this quarter, we initiated a Phase IIa proof-of-concept study of RDEA806, a pro-drug of RDEA594, which should allow us to provide an early confirmation of RDEA594's activity in the target population of patients with gout."
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.
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