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news.TorreyPines Therapeutics has initiated a Phase I clinical trial to evaluate the analgesic effect of NGX426, the oral prodrug of its lead product candidate, tezampanel.
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The randomized, double-blind, placebo-controlled Phase I trial will enroll 18 healthy volunteers at a single center in the US. The trial is designed to evaluate the compound’s safety and tolerability and to assess the time of onset, magnitude and duration of its analgesic effect.
Specifically, the study will evaluate the effect of NGX426 on hyperalgesia, an abnormally increased pain state, and allodynia, pain resulting from normally non-painful stimuli to the skin, induced by intradermal injections of capsaicin. The primary endpoint is subject self-report of spontaneous pain following the injection of capsaicin.
Subjects in the trial, which involves the recognized and validated capsaicin-induced pain model, will receive single doses of 90mg and 150mg of NGX426 versus placebo in a three-way crossover design.
Neil Kurtz, president and CEO of TorreyPines, said: “This capsaicin study, if successful, will enable us to further take advantage of the versatility of NGX426 and the overall tezampanel franchise.”