[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07709494":3,"trial-entities:NCT07709494":125,"trial-summary:NCT07709494":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":46,"secondary_outcomes":52,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":103,"locations":106,"central_contacts":116,"overall_officials":122,"references":123,"see_also_links":124},"NCT07709494","Rev-56-001","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","RECRUITING","2027-06","2026-07","2026-07-28","2026-07-13","Revagenix, Inc.","INDUSTRY",false,"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.",null,[19,20],"Healthy Participants","Non-cystic Fibrosis Bronchiectasis",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE1",{"count":27,"type":28},64,"ESTIMATED",[30,42],{"type":31,"name":32,"description":33,"armGroupLabels":34},"COMBINATION_PRODUCT","Rev-56 for Inhalation","administered by inhalation via an investigational nebulizer device",[35,36,37,38,39,40,41],"Cohort 1a","Cohort 1b","Cohort 2a","Cohort 2b","Cohort 3a","Cohort 4a","Optional Cohort 5a",{"type":43,"name":44,"description":33,"armGroupLabels":45},"DRUG","Placebo: Normal saline",[35,36,37,38,39,40,41],[47,50],{"measure":48,"timeFrame":49},"Incidence and severity of treatment-emergent adverse events (AEs)","21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)",{"measure":51,"timeFrame":49},"Number of participants with clinically significant abnormalities in lab parameters, vital signs, respiratory function, and ECG parameters graded by FDA Toxicity Grading Scale (for healthy participants) and DAIDS Toxicity Tables (for NCFB patients)",[53,56,58,60,62,64,66,68,70,73],{"measure":54,"timeFrame":55},"Maximum observed concentration (Cmax) of Rev-56","Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation",{"measure":57,"timeFrame":55},"Time to Cmax of Rev-56 (Tmax)",{"measure":59,"timeFrame":55},"Area under the curve from time 0 to last measurable concentration (AUC0-last)",{"measure":61,"timeFrame":55},"Area under the curve from time 0 to 24 hours after completion of dosing (AUC0-24)",{"measure":63,"timeFrame":55},"Area under the curve from time 0 to infinity (AUC0-inf)",{"measure":65,"timeFrame":55},"Clearance of Rev-56 (CL\u002FF)",{"measure":67,"timeFrame":55},"Half-life of Rev-56 (t½)",{"measure":69,"timeFrame":55},"Volume of distribution of Rev-56 (Vz\u002FF)",{"measure":71,"timeFrame":72},"Minimum observed concentration of Rev-56 (Cmin)","NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation",{"measure":74,"timeFrame":75},"Mean P. aeruginosa burden (CFU\u002FmL) in sputum culture compared to baseline","28 days (NCFB patients with P. aeruginosa)","ALL","18 Years","80 Years",true,{"inclusion":81,"exclusion":92,"raw_text":102},[82,83,84,85,86,87,88,89,90,91],"Healthy male and female participants aged 18 to 55 years, inclusive","Body mass index \\> 18 to ≤ 32 kg\u002Fm\\^2","Forced expiratory volume in 1 second (FEV1) ≥ 80%","Creatinine clearance ≥ 90 mL\u002Fmin","Normal laboratory values and physical exam at screening, or Grade 1 abnormalities that are not clinically significant","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\u002FmL","FEV1 ≥ 50% (post bronchodilator)",[93,94,95,96,97,98,99,100,101],"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\u002Fchemical abuse","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","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",[104,105],"ADULT","OLDER_ADULT",[107],{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":112,"geoPoint":113},"Syneos Health Miami","Miami","Florida","33136","United States",{"lat":114,"lon":115},25.77427,-80.19366,[117],{"name":118,"role":119,"phone":120,"email":121},"Chrissy Morgenthaler","CONTACT","619-512-3538","revagenixclinicaltrials@revagenix.com",[],[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[127,20],"Healthy Volunteers",[],{"nct_id":4,"found":79,"summary":130,"prompt_version":140},{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is an interventional Phase 1a\u002F1b study. Part A involves healthy participants randomized to Rev-56 or placebo, and Part B involves NCFB patients receiving multiple doses of Rev-56.","completed","Phase 1a\u002F1b Study of Inhaled Rev-56 for P. Aeruginosa in Healthy Volunteers and NCFB Patients","This study is testing an inhaled medication called Rev-56. It's a Phase 1a\u002F1b study, which means it's an early-stage trial looking at the safety and how the body handles the drug. Researchers also want to see how Rev-56 affects bacteria (microbiological response). Part A involves healthy volunteers, while Part B focuses on adults with non-cystic fibrosis bronchiectasis (NCFB) who have a chronic P. aeruginosa infection. The study compares Rev-56 to a placebo (an inactive substance like normal saline). The main goals are to track any side effects and changes in lab tests, vital signs, and breathing function. Around 64 people aged 18 to 80 are planned to enroll.","Safety will be monitored for 21 days in healthy participants and 28 days in NCFB patients after treatment.",108,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]