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
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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 Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1a |
3.5 mg Rev-56 or placebo single dose |
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Experimental Cohort 2a |
7 mg Rev-56 or placebo single dose |
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|
Experimental Cohort 3a |
14 mg Rev-56 or placebo single dose |
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|
Experimental Cohort 4a |
28 mg Rev-56 or placebo single dose |
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|
Experimental Optional Cohort 5a |
≤56 mg Rev-56 or placebo single dose |
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|
Experimental Cohort 1b |
≤28 mg Rev-56 or placebo once daily for 7 days |
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Experimental Cohort 2b |
≤28 mg Rev-56 or placebo twice daily for 7 days |
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Recruiting Locations
Miami, Florida 33136
More Details
- Status
- Recruiting
- Sponsor
- Revagenix, Inc.