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

Inclusion criteria

(Healthy Participants):

• Healthy male and female participants aged 18 to 55 years, inclusive
• Body mass index > 18 to ≤ 32 kg/m^2
• Forced expiratory volume in 1 second (FEV1) ≥ 80%
• Creatinine clearance ≥ 90 mL/min
• Normal laboratory values and physical exam at screening, or Grade 1 abnormalities that are not clinically significant

Inclusion criteria

(NCFB Patients with P. aeruginosa):

• Male and female NCFB patients aged 18 to 80 years, inclusive
• Bronchiectasis confirmed by prior computerized tomography (CT) scan
• Chronic P. aeruginosa infection (≥ 2 positive cultures within prior 12 months)
• Screening sputum culture positive for P. aeruginosa at ≥ 10^4 CFU/mL
• FEV1 ≥ 50% (post bronchodilator)

Exclusion criteria

(Healthy Participants):

• 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

Exclusion criteria

(NCFB Patients with P. aeruginosa):

• Primary asthma, chronic obstructive pulmonary disease (COPD), or cystic fibrosis (CF)
• More than 2 pulmonary exacerbations requiring IV antibiotics within 12 months prior to screening
• Receipt of antibiotics (excluding macrolides) within 30 days prior to screening
• Clinically significant hemoptysis requiring intervention within 30 days prior to screening
• Receiving anti-infective treatment for concurrent nontuberculosis mycobacteria (NTM) or fungal infection