Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS

Summary

This Phase IIa pilot study is a placebo controlled, multicenter study to evaluate safety and efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients. The subjects will be randomized 1:1 to either BIO-11006 125 mg twice daily plus standard of care or placebo plus standard of care. The treatment will continue for up to 28 days. The study will enroll up to 40 adult ARDS patients in up to eight sites within USA.

Timeline

Start

2017-08-05

Primary completion

2020-03-30

Completion

2020-06-15

Drugs

Indications