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.
Healthy male and female participants aged 18 to 55 years, inclusive
Body mass index > 18 to ≤ 32 kg/m²
Forced expiratory volume in 1 second (FEV1) ≥ 80%
Creatinine clearance ≥ 90 mL/min
Clinically significant medical history
Acute illness within 4 weeks of screening
Current smoker or nicotine user
History of alcohol abuse (within prior 12 months) or drug/chemical abuse
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Treatment groupsSee each treatment group below.
Revagenix, Inc.
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator