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news.Alexza Pharmaceuticals has initiated a Phase I clinical trial with AZ-007 or Staccato zaleplon, an inhalation product candidate being developed for the treatment of insomnia patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep.
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The AZ-007 Phase I clinical trial is projected to enroll approximately 40 healthy volunteers at a single US clinical center. The purpose of this trial is to assess the safety, tolerability and pharmacokinetic parameters of a single dose of AZ-007. Using a double-blind, randomized, dose-escalation trial design, four doses of AZ-007 (ranging from 0.5mg to 4mg) will be compared to placebo.
Alexza believes the novel, non-invasive nature and possible rapid pharmacokinetic properties resulting from inhaled zaleplon administration via the Staccato system make AZ-007 a viable product candidate for clinical development in insomnia.
Alexza also announced a status update on its clinical pipeline, including confirming the initiation of its first AZ-004 Phase III clinical trial by the end of the first quarter of 2008.