The AZ-007 Phase I clinical trial enrolled 40 healthy volunteers at a single US clinical center. The purpose of this trial was 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 0.5 to 4.0mg) were compared to placebo.
AZ-007 (Staccato zaleplon) delivered an IV-like pharmacokinetic profile with a median time to peak venous concentration (Tmax) of 1.6 minutes. Zaleplon exposure was dose proportional across the four doses studied, as calculated by power analysis. Pharmacodynamics, measured as sedation assessed on a 100mm visual-analog scale, showed onset of effect as early as two minutes after dosing with AZ-007.
There were no serious adverse events. These data indicate a rapid onset of effect, apparently directly related to the IV-like pharmacokinetics, and showed that AZ-007 was generally safe and well tolerated in this population of healthy volunteers.