64 Participants NeededMy employer runs this trial

Inhaled Rev-56 for Bronchiectasis

CM
Overseen ByChrissy Morgenthaler
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and metabolism of an inhaled treatment called Rev-56. It targets individuals with non-cystic fibrosis bronchiectasis, a lung condition causing persistent cough and mucus, who have a chronic infection with the bacteria P. aeruginosa. Healthy adults may also participate to help test single doses of this treatment. Those with bronchiectasis confirmed by a CT scan and frequent positive tests for P. aeruginosa in sputum (lung mucus) within the last year might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that inhaled Rev-56 is likely to be safe for humans?

Research has shown that inhaled antibiotics, such as Rev-56, hold promise in treating bronchiectasis and appear to be safe. Although specific data on Rev-56 is not yet available, similar treatments have been well-tolerated. This trial serves as an early test to assess the safety of Rev-56 in humans and to observe the body's response. Researchers closely monitor participants for any side effects. As a Phase 1 trial, the primary goal is to ensure the safety of Rev-56.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about Rev-56 for inhalation because it offers a unique delivery method for treating bronchiectasis. Unlike traditional treatments, which often involve oral medications or injections, Rev-56 is delivered directly to the lungs via inhalation, potentially allowing for faster action and fewer systemic side effects. Additionally, the formulation of Rev-56 is designed to target the airways specifically, which could provide more direct relief from the symptoms associated with bronchiectasis. This targeted approach may improve breathing efficiency and quality of life for patients more effectively than current methods.

What evidence suggests that inhaled Rev-56 might be an effective treatment for bronchiectasis?

Research shows that inhaled antibiotics can improve breathing in people with bronchiectasis, a lung condition where the airways widen unusually. These treatments slightly enhance patients' quality of life by easing symptoms. Previous studies have shown that inhaled antibiotics effectively reduce bacteria in the lungs of patients with non-cystic fibrosis bronchiectasis. This reduction can lead to fewer lung flare-ups, better lung function, and overall improved well-being. In this trial, Rev-56, the inhaled treatment under study, aims to achieve similar results by managing symptoms and reducing lung infections.46789

Are You a Good Fit for This Trial?

This trial is for adults who are either healthy or have non-cystic fibrosis bronchiectasis (NCFB) with chronic P. aeruginosa infection. Participants must meet health requirements set by the study and cannot join if they have conditions that could interfere with participation.

Inclusion Criteria

Healthy Participants: Forced expiratory volume in 1 second (FEV1) ≥ 80%
Healthy Participants: Creatinine clearance ≥ 90 mL/min
NCFB Patients with P. aeruginosa: Screening sputum culture positive for P. aeruginosa at ≥ 10^4 CFU/mL
See 7 more

Exclusion Criteria

I have asthma, COPD, or cystic fibrosis along with P. aeruginosa infection.
Healthy Participants: Clinically significant medical history
I am being treated for NTM or fungal infection while having P. aeruginosa and NCFB.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Treatment

Single doses of inhaled Rev-56 are administered to healthy participants across up to 5 cohorts

1 day per dose
1 visit per dose

Phase 1b Treatment

Multiple doses of inhaled Rev-56 are administered to NCFB patients with P. aeruginosa, evaluating once daily and twice daily dosing

7 days
Daily visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Rev-56 for Inhalation

Trial Overview

The study tests inhaled Rev-56 compared to a placebo (saline). Healthy volunteers get single doses, while NCFB patients receive multiple doses once or twice daily. The main focus is on safety, tolerability, and how the body handles the drug.

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Group I: Optional Cohort 5aExperimental Treatment2 Interventions
Group II: Cohort 4aExperimental Treatment2 Interventions
Group III: Cohort 3aExperimental Treatment2 Interventions
Group IV: Cohort 2bExperimental Treatment2 Interventions
Group V: Cohort 2aExperimental Treatment2 Interventions
Group VI: Cohort 1bExperimental Treatment2 Interventions
Group VII: Cohort 1aExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Revagenix, Inc.

Lead Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Citations

The Efficacy and Safety of Inhaled Antibiotics for the Treatment ...

Inhaled antibiotics likely lead to a slight increase in the Quality of Life Questionnaire-Bronchiectasis respiratory symptom score (mean difference, 2.51; 95% ...

Effects of long-term tobramycin inhalation solution (TIS) once ...

We investigated the efficacy and safety of maintenance TIS once daily (OD) in frequent exacerbating bronchiectasis patients chronically infected ...

Revagenix Doses First Participant in Phase 1 Trial of Rev- ...

Part A of the study evaluates the safety, tolerability, and pharmacokinetics of inhaled (nebulized) Rev-56 in healthy volunteers. Topline data ...

Exacerbations of bronchiectasis | European Respiratory Society

Landmark studies on CADs have shown that repeated exacerbations lead to faster lung function decline and higher mortality [7–10]. In bronchiectasis, ...

Table of Contents

Bronchiectasis results in significant negative effects on quality of life due to impaired social and physical functioning related to the ...

Revagenix Doses First Participant in Phase 1 Trial of Rev- ...

Part A of the study evaluates the safety, tolerability, and pharmacokinetics of inhaled (nebulized) Rev-56 in healthy volunteers.

Revagenix Doses First Participant in Phase 1 Trial of Rev- ...

Part A of the study will evaluate safety, tolerability, and pharmacokinetics in healthy volunteers, with topline data expected by year-end 2026.

A Phase 1a/1b Study to Investigate the Safety, Tolerability, ...

This is a Phase 1a/1b study to test the safety, tolerability, microbiological response, and pharmacokinetics of inhaled Rev-56 compared to ...

Revagenix Doses First Participant in Phase 1 Trial of Rev-56 ...

Part A of the study evaluates the safety, tolerability, and pharmacokinetics of inhaled (nebulized) Rev-56 in healthy volunteers.