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

Part of paid clinical trials in Miami, Florida.

Sponsor
Revagenix, Inc.
Study ID
NCT07709494
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants
  • Non-cystic Fibrosis Bronchiectasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Rev-56 for Inhalation — COMBINATION_PRODUCT
    administered by inhalation via an investigational nebulizer device
  • Placebo: Normal saline — DRUG
    administered by inhalation via an investigational nebulizer device

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Jul 13, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Syneos Health MiamiMiamiFlorida33136-

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By research site
Syneos Health Miami· Miami, FL

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