83
Participants
Start Date
May 24, 2021
Primary Completion Date
December 2, 2022
Study Completion Date
December 2, 2022
AER-901 Solution for Nebulization
"Part A: participants will be enrolled into 1 of up to 5 sequential cohorts (A1 to A5). Inhaled AER-901 doses of 5, 10, 20, 40, and 80mg are planned.~Part B: participants will be enrolled into 1 of up to 3 cohorts (B1 to B3).~Cohorts B2 and B3 will commence following Part D of the study and following SRC review of safety, tolerability, and PK data. A decision to dose with either a propylene glycol formulation or a sterile water formulation will be made by the SRC at the time of the review of the Part D data.~Part D has a three-part design (Treatment Periods 1 \& 2 separated by a Washout period) and will compare placebo to a single-dose of AER-901 (5 mg/mL QD) followed by two doses of AER-901.~Each cohort will consist of 8 participants (6 receiving AER 901 and 2 receiving placebo)."
Placebo
0.45% sterile saline for injection delivered via the FOX MOBILE device.
CMAX, Adelaide
Lead Sponsor
Aerami Therapeutics
INDUSTRY