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news.OrthoLogic has announced that the FDA has accepted an investigational new drug application for AZX100 in dermal or hypertrophic scarring. The Phase I human clinical trials will begin during the first quarter of 2008.
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The clinical study will be a first-in-man Phase I, randomized, placebo controlled, dose-escalation, single center study in which the safety and tolerability of escalating doses of AZX100 will be evaluated in healthy adult male subjects. A placebo control arm is included in this Phase I study for comparison of injection sites. Approximately 30 adult subjects will be enrolled at an experienced inpatient Phase I study clinic. The primary objective is to evaluate the initial safety and tolerability of AZX100 drug product in healthy adult subjects.
Randolph Steer, president of OrthoLogic, said: “We are now ready to proceed with our Phase I human clinical trial program.”