126-20 | SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects

Overview

“A Phase 1/2a randomized, double-blind, two-part, dose-ascending, multicenter study of the safety and pharmacokinetics of AR-501 (gallium citrate), administered via inhalation, in healthy adult and P. aeruginosa infected cystic fibrosis subjects”

This is a two-part, randomized, double-blind, placebo-controlled, ascending-dose study to evaluate the safety and PK of AR-501, a gallium citrate solution for inhalation, in adult healthy volunteer (HV) subjects and CF subjects, and efficacy in CF subjects. Phase 1 of the study in HV subjects will consist of a single-ascending-dose (SAD) cohort, followed by the HV multiple-ascending-dose (MAD) cohort. Phase 2a of the study in CF subjects will consist of a MAD study design.