Characterisation of pharmacokinetics, safety and tolerability in a first-in-human study for AZD8154, a novel inhaled selective PI3Kgammadelta dual inhibitor targeting airway inflammatory disease

This randomized, Phase I, three-part, first-in-human study evaluated the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of inhaled AZD8154 in 78 healthy male and female volunteers. In one part of the study, AZD8154 was given at doses of 0.6 mg (n=6), 1.8 mg (n=6) and 3.1 mg (n=6), with a single dose on Day 1 followed by repeated once-daily doses on Days 4–12; during this part of the study, post-inhalation cough monitoring was performed using the Vitalograph VitaloJAK cough monitor.