A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharma… (NCT07709494) | Clinical Trial Compass
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
United States64 participantsStarted 2026-07-13
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 infect…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of treatment-emergent adverse events (AEs)
Timeframe: 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
2
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)
Timeframe: 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)