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Inhaled experimental drug targets tough lung infections

NCT ID NCT07709494

Disease control Sponsor: Revagenix, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This early-stage trial tests an inhaled drug called Rev-56 in healthy volunteers and in people with non-cystic fibrosis bronchiectasis who have chronic Pseudomonas aeruginosa lung infections. The study checks whether the drug is safe and how the body processes it, comparing Rev-56 to a placebo. If it passes safety checks, it may offer a new way to control these stubborn infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an inhaled experimental drug called Rev-56
What this could lead to
If successful, this could lead to a new inhaled treatment for chronic Pseudomonas infections in people with bronchiectasis.
What could go wrong
This is an early Phase 1 trial focused on safety, so it is too soon to know if Rev-56 will effectively treat infections. Side effects or lack of benefit may emerge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bronchiectasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy participants Non-cystic fibrosis bronchiectasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Syneos Health Miami

    RECRUITING

    Miami, Florida, 33136, United States

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