Condition: Healthy Participants · Non-cystic Fibrosis Bronchiectasis · Sponsor: Revagenix, Inc.
This is a Phase 1a/1b study to test the safety, tolerability, microbiological response, and pharmacokinetics of inhaled Rev-56 compared to placebo in adult healthy participants and non-cystic fibrosis bronchiectasis (NCFB) patients with P. aeruginosa, respectively. Phase 1a (Part A) will evaluate single doses of inhaled Rev-56 in adult healthy participants and includes up to 5 cohorts. Eligible participants will be randomized to active treatment or placebo in a 3:1 randomization scheme. Phase 1b (Part B) will evaluate the safety, tolerability, microbiological response, and pharmacokinetics of multiple doses of inhaled Rev-56 in NCFB patients with P. aeruginosa and includes 2 cohorts evaluating once daily dosing and twice daily dosing, respectively. Eligible participants will be randomized to active treatment or placebo in a 2:1 randomization scheme.
This description comes directly from the study's public registry record.
Chrissy Morgenthaler · 619-512-3538 · revagenixclinicaltrials@revagenix.com
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| Syneos Health Miami | Miami, Florida, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07709494