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Phase 1a/1b Study of Inhaled Rev-56 for P. Aeruginosa in Healthy Volunteers and NCFB Patients

This study is testing an inhaled medication called Rev-56. It's a Phase 1a/1b study, which means it's an early-stage trial looking at the safety and how the body handles the drug. Researchers also want to see how Rev-56 affects bacteria (microbiological response). Part A involves healthy volunteers, while Part B focuses on adults with non-cystic fibrosis bronchiectasis (NCFB) who have a chronic P. aeruginosa infection. The study compares Rev-56 to a placebo (an inactive substance like normal saline). The main goals are to track any side effects and changes in lab tests, vital signs, and breathing function. Around 64 people aged 18 to 80 are planned to enroll.

Study design
This is an interventional Phase 1a/1b study. Part A involves healthy participants randomized to Rev-56 or placebo, and Part B involves NCFB patients receiving multiple doses of Rev-56.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for 21 days in healthy participants and 28 days in NCFB patients after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Revagenix, Inc.
~64 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Rev-56 for InhalationPlacebo: Normal saline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of treatment-emergent adverse events (AEs)
Measured over 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
+1 more outcome measured

Conditions

Healthy Participants
Non-cystic Fibrosis Bronchiectasis

Explore related trials

Healthy VolunteersNon-cystic Fibrosis Bronchiectasis

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Chrissy Morgenthaler
[email protected]
619-512-3538
Email the study team

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Eligibility criteria

Inclusion

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)

Exclusion

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
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

What this trial measures

  • 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)