Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the
safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation
solution (AER-901) in healthy adult volunteers. This study consists of 2 parts and an
optional third part:
- Part A: double-blind, placebo-controlled, single ascending dose (SAD).
- Part B: double-blind, placebo-controlled, multiple-ascending dose (MAD).
- Part C (optional): an open-label, single-dose, 2-way crossover. Each part of the study
will include a 28-day screening period, a treatment period, and follow-up period.