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
Sequential
Rev-56 for Inhalation
Combination productadministered by inhalation via an investigational nebulizer device
Placebo: Normal saline
Drugadministered by inhalation via an investigational nebulizer device
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Treatment groupsSee each treatment group below.
Incidence and severity of treatment-emergent adverse events (AEs)
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)
Maximum observed concentration (Cmax) of Rev-56
Time to Cmax of Rev-56 (Tmax)
Area under the curve from time 0 to last measurable concentration (AUC0-last)
Area under the curve from time 0 to 24 hours after completion of dosing (AUC0-24)
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Revagenix, Inc.
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
