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

NCT07709494 · tracked via the Priya Life Science USA tracker

Sponsor

Revagenix, Inc.

Phase

Phase 1

Started

2026-07-13

Last updated

2026-07-28

Condition(s) studied

Healthy ParticipantsNon-cystic Fibrosis Bronchiectasis

Investigational drug(s) / intervention(s)

Rev-56 for InhalationPlacebo: Normal saline

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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

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

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)

Facility	City	Region	Status
Syneos Health Miami	Miami	Florida	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07709494 on ClinicalTrials.gov ↗ ← All trials in the USA