WS05.06 Phase 1/2a randomized, double-blind, placebo-controlled study: safety, Pk, and Efficacy outcome measures of inhaled Gallium Citrate (AR-501) in P Aeruginosa infected Cystic Fibrosis patients

Abstract

Background: AR-501, an inhaled novel iron analog disrupts microbial iron-dependent metabolic pathways, resulting in antimicrobial activity against bacteria, NTM, and fungi. This Ph1/2a study will have data readout by mid-2023 (www.clinicaltrials.gov NCT03669614). Inhaled AR-501 in HV’s was generally well tolerated once weekly for 5 weeks. Here we report the preliminary safety, PK, and exploratory efficacy results of once-weekly inhaled AR-501 for 3 doses over four weeks.