drugset
drugset / Trial / NCT04903730

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

NCT04903730 ↗

Phase 1 Completed 83 enrolled Aerami Therapeutics
RandomizedSequentialTriple-blindBasic science

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 3 parts and an optional fourth part.

Timeline

Start
2021-05-24
Primary completion
2022-12-02
Completion
2022-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 5 mg Inhaled
Subject Imatinib Small molecule 10 mg Inhaled
Subject Imatinib Small molecule 20 mg Inhaled
Subject Imatinib Small molecule 40 mg Inhaled
Subject Imatinib Small molecule 80 mg Inhaled

Indications

pulmonary arterial hypertension