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Recruiting NCT07709494

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

Conditions: Healthy Participants, Non-cystic Fibrosis Bronchiectasis

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 64
Sponsor: Revagenix, Inc.

Location: Syneos Health Miami Miami Florida

Summary

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.

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, 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07709494). StuddyBuddy aggregates publicly available trial information.