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.