Home › NCT07709494

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

A Sequential, Phase 1a/1b, Double-blind, 2-part Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Rev-56 for Inhalation Compared With Placebo in Healthy Adult Participants and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic Pseudomonas Aeruginosa

Who can join

Ages 18 to 80 · All sexes · Healthy volunteers welcome

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

About the study

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.

What is being tested

• Rev-56 for Inhalation (combination product)
• Placebo: Normal saline (drug)

Sponsor: Revagenix, Inc. · Participants: 64 · Started: Jul 13, 2026

Contact the study team

• Chrissy Morgenthaler · Phone: 619-512-3538

Official record on ClinicalTrials.gov — NCT07709494

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.