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.
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