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news.Alexza Pharmaceuticals has initiated a phase I clinical trial with its inhalation product candidate AZ-003, which is being developed for the treatment of patients with acute pain episodes.
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AZ-003 is the combination of Alexza’s proprietary Staccato system with fentanyl, a drug belonging to the class of compounds known as opioid analgesics. AZ-003 is a hand-held, electrically-heated, multiple dose inhaler designed to generate and deliver excipient-free fentanyl aerosol for deep lung delivery.
The phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single dose of AZ-003 and an equivalent dose of intravenous (IV) fentanyl. Stage 2 is a randomized, double-blind, placebo-controlled dose escalation trail of AZ-003, evaluating multiple doses of fentanyl.
The three primary aims of the phase I clinical trial are to evaluate the pharmacokinetics (PK) and absolute bioavailability for AZ-003, compare the AZ-003 PK profile to the IV fentanyl PK profile, and examine the tolerability and safety of AZ-003 in a non-opioid-tolerant, healthy volunteer population.