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

NCT07709494 | Recruiting Phase 1 FDA Drug FDA Device

• 2 other identifiers: Rev-56-00175N93022C00061
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (10)

• Maximum observed concentration (Cmax) of Rev-56

  Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation

• Time to Cmax of Rev-56 (Tmax)

  Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation

• Area under the curve from time 0 to last measurable concentration (AUC0-last)

  Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation

• Area under the curve from time 0 to 24 hours after completion of dosing (AUC0-24)

  Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation

• Area under the curve from time 0 to infinity (AUC0-inf)

  Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation

Study Arms (7)

Cohort 1a

EXPERIMENTAL

3.5 mg Rev-56 or placebo single dose

Combination Product: Rev-56 for Inhalation; Drug: Placebo: Normal saline

Cohort 2a

EXPERIMENTAL

7 mg Rev-56 or placebo single dose

Combination Product: Rev-56 for Inhalation; Drug: Placebo: Normal saline

Cohort 3a

EXPERIMENTAL

14 mg Rev-56 or placebo single dose

Combination Product: Rev-56 for Inhalation; Drug: Placebo: Normal saline

Cohort 4a

EXPERIMENTAL

28 mg Rev-56 or placebo single dose

Combination Product: Rev-56 for Inhalation; Drug: Placebo: Normal saline

Optional Cohort 5a

EXPERIMENTAL

≤56 mg Rev-56 or placebo single dose

Combination Product: Rev-56 for Inhalation; Drug: Placebo: Normal saline

Cohort 1b

EXPERIMENTAL

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

Combination Product: Rev-56 for Inhalation; Drug: Placebo: Normal saline

Cohort 2b

EXPERIMENTAL

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

Combination Product: Rev-56 for Inhalation; Drug: Placebo: Normal saline

Interventions

Rev-56 for Inhalation COMBINATION_PRODUCT

administered by inhalation via an investigational nebulizer device

Cohort 1a; Cohort 1b; Cohort 2a; Cohort 2b; Cohort 3a; Cohort 4a; Optional Cohort 5a

Placebo: Normal saline DRUG

administered by inhalation via an investigational nebulizer device

Cohort 1a; Cohort 1b; Cohort 2a; Cohort 2b; Cohort 3a; Cohort 4a; Optional Cohort 5a

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Revagenix, Inc.: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Syneos Health Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Interventions

Inhalation

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Chrissy Morgenthaler

CONTACT

619-512-3538; revagenixclinicaltrials@revagenix.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 16, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

US (1)