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

Recruiting Phase 1 Interventional Study
Healthy Participants Non-cystic Fibrosis Bronchiectasis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
64 (estimated)
Sponsor
Revagenix, Inc. · Industry
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About This Trial
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 p…
Trial Locations
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Eligibility Criteria
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, …
Contacts

Chrissy Morgenthaler

619-512-3538

revagenixclinicaltrials@revagenix.com

CONTACT