[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630830":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":66,"collaborators":30,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":30,"enrollmentInfo":78,"targetDuration":30,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":90,"whyStopped":30,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"MicrobiotiX Co., Ltd","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-dose cohort (Cohort A)","EXPERIMENTAL","Participants in the low-dose cohort (Cohort A) will receive a single intravenous infusion of MP101 in addition to standard antibiotic therapy.",[13,14],"Biological: MP101","Drug: Antibiotics",{"label":16,"type":10,"description":17,"interventionNames":18},"High-dose cohort (Cohort B)","Participants in the high-dose cohort (Cohort B) will receive a single intravenous infusion of MP101 in addition to standard antibiotic therapy.",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo group","PLACEBO_COMPARATOR","Participants in the placebo group will receive a single intravenous infusion of placebo in addition to standard antibiotic therapy.",[14],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","MP101","This clinical trial is a Phase 1 study with a randomized, double-blind, placebo-controlled, single-dose, sequential dose-escalation design and consists of two dose cohorts. After the safety of the low-dose cohort (Cohort A) is evaluated, dosing will proceed to the high-dose cohort (Cohort B).\n\nThe investigational product, MP101, is a cocktail formulation comprising two bacteriophages. Participants in Cohort A will receive low dose, and participants in Cohort B will receive high dose. MP101 will be administered as a single intravenous infusion. The placebo is a clear solution with the same appearance as MP101 but without bacteriophages, and it will be administered in the same manner.",[16,9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Antibiotics","All study subjects will receive concomitant antibiotic therapy. The choice of the concomitant antibiotic will be based on the results of antibiotic susceptibility testing and will follow the best available therapy, as determined by the investigator.",[16,9,20],[37],"Standard antibiotic therapy",[39],{"name":40,"affiliation":41,"role":42},"Jun Yong Choi","Severance Hospital","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":48},"Sangmin Lee, Director","CONTACT","82-10-2807-7489","smlee@microbiotix.net",[50],{"facility":41,"status":30,"city":51,"state":52,"zip":53,"country":54,"countryCode":30,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Seoul","Seodaemun-gu","03722","South Korea",{"type":56,"coordinates":57},"Point",[58,59],126.9784,37.566,{"lat":59,"lon":58},[62],{"name":63,"role":46,"phone":64,"phoneExt":30,"email":65},"Jun Yong Choi, Professor","82-2-2228-1974","seran@yuhs.ac",{"type":67,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100630830","phase-1-mp101-in-adults-with-acute-pseudomonas-aeruginosa-pneumonia-100630830",false,"NCT07492771","MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia","A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of MP101 in Adult Patients With Acute Pseudomonas Aeruginosa Pneumonia","MP101-1001","Inclusion Criteria:\n\n* Subjects aged 19 years or older.\n* Clinical diagnosis of acute pneumonia with radiologic evidence of pulmonary infiltrates.\n* Confirmed Pseudomonas aeruginosa (PA) infection via valid respiratory specimens.\n* PA isolate demonstrates susceptibility to MP101 and non-susceptibility to current antibiotic therapy.\n* Adequate organ function as defined by hematological, hepatic, and renal laboratory parameters .\n\nExclusion Criteria:\n\n* Persistent septic shock or hemodynamically unstable condition.\n* Active pulmonary tuberculosis or suspected non-bacterial pneumonia.\n* Significant pleural effusion or lung abscess requiring therapeutic drainage.\n* Clinically significant cardiovascular, hepatic, or renal impairment .\n* Immunocompromised status or history of hematological malignancies.\n* Known hypersensitivity to bacteriophages, study components, or concomitant antibiotics.\n* Participation in another clinical trial within 30 days prior to screening.\n* Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study.","ALL","19 Years",{"count":79,"type":80},18,"ESTIMATED","INTERVENTIONAL",[83],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MP101 administered in addition to standard antibiotic therapy in adult patients with acute Pseudomonas aeruginosa pneumonia. The study will also assess the pharmacokinetic and pharmacodynamic characteristics of MP101 and its antibacterial activity, including changes in P. aeruginosa burden in sputum and changes in susceptibility to MP101 and concomitant antibiotics.",[86,87],"Pneumonia - Bacterial","Pseudomonas Aeruginosa Infection",[89],"Acute Pseudomonas Aeruginosa Pneumonia","NOT_YET_RECRUITING","2026-05-22",{"date":93,"type":94},"2026-05-26","ACTUAL",{"date":96,"type":80},"2026-06-15",{"date":98,"type":80},"2026-12",{"name":5,"class":6},1]