SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1/2a randomized, double-blind, two-part, dose-ascending, multicenter study of
AR-501 (gallium citrate) solution, administered via inhalation, in healthy adult and P.
aeruginosa infected cystic fibrosis (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. The
study will evaluate the safety and pharmacokinetic (PK) profile of single and repeat
administrations of inhaled AR-501 solution in healthy adults, and the safety, PK and efficacy
of repeat administrations of inhaled AR-501 solution in P. aeruginosa infected CF subjects.