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

A Sequential, Phase 1a/1b, Double-blind, 2-part Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Rev-56 for Inhalation Compared With Placebo in Healthy Adult Participants and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic Pseudomonas Aeruginosa

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Participants; Non-cystic Fibrosis Bronchiectasis
• Intervention / Treatment: Combination product: Rev-56 for Inhalation; Drug: Placebo: Normal saline

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chrissy Morgenthaler; Phone Number: 619-512-3538; Email: revagenixclinicaltrials@revagenix.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Syneos Health Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1a; 3.5 mg Rev-56 or placebo single dose	Combination product: Rev-56 for Inhalation; administered by inhalation via an investigational nebulizer device; Drug: Placebo: Normal saline; administered by inhalation via an investigational nebulizer device
Experimental: Cohort 2a; 7 mg Rev-56 or placebo single dose	Combination product: Rev-56 for Inhalation; administered by inhalation via an investigational nebulizer device; Drug: Placebo: Normal saline; administered by inhalation via an investigational nebulizer device
Experimental: Cohort 3a; 14 mg Rev-56 or placebo single dose	Combination product: Rev-56 for Inhalation; administered by inhalation via an investigational nebulizer device; Drug: Placebo: Normal saline; administered by inhalation via an investigational nebulizer device
Experimental: Cohort 4a; 28 mg Rev-56 or placebo single dose	Combination product: Rev-56 for Inhalation; administered by inhalation via an investigational nebulizer device; Drug: Placebo: Normal saline; administered by inhalation via an investigational nebulizer device
Experimental: Optional Cohort 5a; ≤56 mg Rev-56 or placebo single dose	Combination product: Rev-56 for Inhalation; administered by inhalation via an investigational nebulizer device; Drug: Placebo: Normal saline; administered by inhalation via an investigational nebulizer device
Experimental: Cohort 1b; ≤28 mg Rev-56 or placebo once daily for 7 days	Combination product: Rev-56 for Inhalation; administered by inhalation via an investigational nebulizer device; Drug: Placebo: Normal saline; administered by inhalation via an investigational nebulizer device
Experimental: Cohort 2b; ≤28 mg Rev-56 or placebo twice daily for 7 days	Combination product: Rev-56 for Inhalation; administered by inhalation via an investigational nebulizer device; Drug: Placebo: Normal saline; administered by inhalation via an investigational nebulizer device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Clearance of Rev-56 (CL/F)	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
Half-life of Rev-56 (t½)	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
Volume of distribution of Rev-56 (Vz/F)	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
Minimum observed concentration of Rev-56 (Cmin)	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
Mean P. aeruginosa burden (CFU/mL) in sputum culture compared to baseline	28 days (NCFB patients with P. aeruginosa)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Circulatory and Respiratory Physiological Phenomena; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Inhalation
• Other Study ID Numbers: Rev-56-001; 75N93022C00061 (Other Identifier: NIAID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes