NCT07709494Active, not recruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 64 (estimated)
First submitted: 2 Jul 2026
Start date: 13 Jul 2026
Primary completion date: 31 Jul 2027
Lead sponsor: Revagenix, Inc.
Diseases: Cystic fibrosis
NCT number: NCT07709494

What you commit to

Study type: Interventional · Phase 1
Planned participants: 64
From 13 Jul 2026 to the primary completion date, 31 Jul 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

History of alcohol abuse (within prior 12 months) or drug/chemical abuse
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

Other illness

Acute illness within 4 weeks of screening
Primary asthma, chronic obstructive pulmonary disease (COPD), or cystic fibrosis (CF)

Other

Clinically significant medical history
Current smoker or nicotine user

Who the study is looking for

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
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)

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Syneos Health Miami Coordinator of this site? Confirm its status	Miami	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.