[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647483":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":45,"centralContacts":50,"locations":56,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":45,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":45,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":45,"overallStatus":59,"whyStopped":45,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Revagenix, Inc.","INDUSTRY",[8,15,19,23,27,31,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1a","EXPERIMENTAL","3.5 mg Rev-56 or placebo single dose",[13,14],"Combination Product: Rev-56 for Inhalation","Drug: Placebo: Normal saline",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 2a","7 mg Rev-56 or placebo single dose",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort 3a","14 mg Rev-56 or placebo single dose",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Cohort 4a","28 mg Rev-56 or placebo single dose",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Optional Cohort 5a","≤56 mg Rev-56 or placebo single dose",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Cohort 1b","≤28 mg Rev-56 or placebo once daily for 7 days",[13,14],{"label":36,"type":10,"description":37,"interventionNames":38},"Cohort 2b","≤28 mg Rev-56 or placebo twice daily for 7 days",[13,14],[40,46],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"COMBINATION_PRODUCT","Rev-56 for Inhalation","administered by inhalation via an investigational nebulizer device",[9,32,16,36,20,24,28],null,{"type":47,"name":48,"description":43,"armGroupLabels":49,"otherNames":45},"DRUG","Placebo: Normal saline",[9,32,16,36,20,24,28],[51],{"name":52,"role":53,"phone":54,"phoneExt":45,"email":55},"Chrissy Morgenthaler","CONTACT","619-512-3538","revagenixclinicaltrials@revagenix.com",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":45},"Syneos Health Miami","RECRUITING","Miami","Florida","33136","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-80.19366,25.77427,{"lat":69,"lon":68},{"type":72,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[74],{"name":75,"class":76},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","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":89,"type":90},64,"ESTIMATED","INTERVENTIONAL",[93],"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.",[96,97],"Healthy Participants","Non-cystic Fibrosis Bronchiectasis","2026-07-27",{"date":100,"type":101},"2026-07-28","ACTUAL",{"date":103,"type":101},"2026-07-13",{"date":105,"type":90},"2027-06",{"name":5,"class":6},1]