Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution

PHASE1CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

May 24, 2021

Primary Completion Date

December 2, 2022

Study Completion Date

December 2, 2022

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

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)."

DRUG

Placebo

0.45% sterile saline for injection delivered via the FOX MOBILE device.

Trial Locations (1)

5000

CMAX, Adelaide

Sponsors
All Listed Sponsors
lead

Aerami Therapeutics

INDUSTRY

NCT04903730 - Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution | Biotech Hunter | Biotech Hunter