[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Revagenix, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100647483","phase-1-a-phase-1a1b-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-100647483",false,"NCT07709494","A Phase 1a\u002F1b 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","A Sequential, Phase 1a\u002F1b, Double-blind, 2-part Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Rev-56 for Inhalation Compared With Placebo in Healthy Adult Participants and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic Pseudomonas Aeruginosa","Inclusion Criteria (Healthy Participants):\n\n* Healthy male and female participants aged 18 to 55 years, inclusive\n* Body mass index \\> 18 to ≤ 32 kg\u002Fm\\^2\n* Forced expiratory volume in 1 second (FEV1) ≥ 80%\n* Creatinine clearance ≥ 90 mL\u002Fmin\n* Normal laboratory values and physical exam at screening, or Grade 1 abnormalities that are not clinically significant\n\nInclusion Criteria (NCFB Patients with P. aeruginosa):\n\n* Male and female NCFB patients aged 18 to 80 years, inclusive\n* Bronchiectasis confirmed by prior computerized tomography (CT) scan\n* Chronic P. aeruginosa infection (≥ 2 positive cultures within prior 12 months)\n* Screening sputum culture positive for P. aeruginosa at ≥ 10\\^4 CFU\u002FmL\n* FEV1 ≥ 50% (post bronchodilator)\n\nExclusion Criteria (Healthy Participants):\n\n* Clinically significant medical history\n* Acute illness within 4 weeks of screening\n* Current smoker or nicotine user\n* History of alcohol abuse (within prior 12 months) or drug\u002Fchemical abuse\n\nExclusion Criteria (NCFB Patients with P. aeruginosa):\n\n* Primary asthma, chronic obstructive pulmonary disease (COPD), or cystic fibrosis (CF)\n* More than 2 pulmonary exacerbations requiring IV antibiotics within 12 months prior to screening\n* Receipt of antibiotics (excluding macrolides) within 30 days prior to screening\n* Clinically significant hemoptysis requiring intervention within 30 days prior to screening\n* Receiving anti-infective treatment for concurrent nontuberculosis mycobacteria (NTM) or fungal infection",true,"ALL","18 Years","80 Years",{"count":21,"type":22},64,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1a\u002F1b 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.\n\nPhase 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.\n\nPhase 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.",[28,29],"Healthy Participants","Non-cystic Fibrosis Bronchiectasis","RECRUITING","2026-07-27",{"date":33,"type":34},"2026-07-28","ACTUAL",{"date":36,"type":34},"2026-07-13",{"date":38,"type":22},"2027-06",{"name":40,"class":41},"Revagenix, Inc.","INDUSTRY",""]