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

Condition(s) studied

Investigational drug(s) / intervention(s)

Rev-56 for Inhalation: administered by inhalation via an investigational nebulizer device

Placebo: Normal saline: administered by inhalation via an investigational nebulizer device

Study summary

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.

Eligibility

Primary outcome measure(s)

• Incidence and severity of treatment-emergent adverse events (AEs) — 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
• Number of participants with clinically significant abnormalities in lab parameters, vital signs, respiratory function, and ECG parameters graded by FDA Toxicity Grading Scale (for healthy participants) and DAIDS Toxicity Tables (for NCFB patients) — 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)

Trial sites (1)

Other trials for the same condition