A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants, Non-cystic Fibrosis Bronchiectasis

In brief

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.

Key facts

Study ID
NCT07709494
Run by
Revagenix, Inc.
People needed
64
Starts
2026-07-13
Expected to finish
2027-06-01
Last updated by the study team
2026-07-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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