Recruiting
Phase 1

Rev-56

Sponsor:

Revagenix, Inc.

Code:

NCT07709494

Conditions

Healthy Participants

Non-cystic Fibrosis Bronchiectasis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Rev-56 for Inhalation

Placebo: Normal saline

Study Details

Brief 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.

Conditions

Healthy Participants

Non-cystic Fibrosis Bronchiectasis

Study ID

NCT07709494

Start date

Jul 13, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1a

3.5 mg Rev-56 or placebo single dose

experimental: Cohort 2a

7 mg Rev-56 or placebo single dose

experimental: Cohort 3a

14 mg Rev-56 or placebo single dose

experimental: Cohort 4a

28 mg Rev-56 or placebo single dose

experimental: Optional Cohort 5a

≤56 mg Rev-56 or placebo single dose

experimental: Cohort 1b

≤28 mg Rev-56 or placebo once daily for 7 days

experimental: Cohort 2b

≤28 mg Rev-56 or placebo twice daily for 7 days

Interventions

Rev-56 for Inhalation

administered by inhalation via an investigational nebulizer device

Placebo: Normal saline

administered by inhalation via an investigational nebulizer device

Primary outcome measure

  • Incidence and severity of treatment-emergent adverse events (AEs) [ Time Frame: 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) [ Time Frame: 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa) ]

Central Contacts and Locations

Central contacts

Chrissy Morgenthaler

619-512-3538revagenixclinicaltrials@revagenix.com

Locations

Syneos Health Miami

Recruiting

Miami, Florida, United States, 33136

More Information

Sponsor

Revagenix, Inc.

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Revagenix, Inc. on 2026-07-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.