[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595693":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":50,"collaborators":52,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Debiopharm International SA","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Single ascending dose (SAD)","EXPERIMENTAL","Participants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1.",[13,14],"Drug: Debio 1453P","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Part 2: Multiple ascending dose (MAD)","Participants will receive multiple oral doses of Debio 1453P or placebo from Day 1 to Day 5. Debio 1453P initial dose in this part will be based on available data from SAD part.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Debio 1453P","Powder for oral solution",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Oral solution",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Debiopharm International S.A","CONTACT","+41213210111","clinicaltrials@debiopharm.com",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"SGS Belgium NV - Clinical Pharmacology Unit","RECRUITING","Edegem","2650","Belgium","BE",{"type":45,"coordinates":46},"Point",[47,48],4.44504,51.15662,{"lat":48,"lon":47},{"type":51,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[53,56,59,62,64],{"name":54,"class":55},"Biomedical Advanced Research and Development Authority","FED",{"name":57,"class":58},"Wellcome Trust","OTHER",{"name":60,"class":61},"Germany's Federal Ministry of Research, Technology and Space (BMFTR)","UNKNOWN",{"name":63,"class":61},"Global Antimicrobial Resistance Innovation Fund-(GAMRIF)",{"name":65,"class":61},"Novo Nordisk Foundation (NNF)","100595693","phase-1-a-first-in-human-study-to-evaluate-safety-tolerability-and-pharmacokinetics-of-single-and-multiple-oral-doses-of-debio-1453p-in-healthy-adults-100595693",false,"NCT07035769","A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults","A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults","Inclusion Criteria\n\n1. Signed and dated written informed consent obtained before undertaking any trial-specific procedures.\n2. Be within the age range of 18 to 55 years, inclusive, at the time of screening.\n3. Have a body mass index (BMI) ≥18.5 and ≤30.0 kg\u002Fm\\^2.\n\nExclusion criteria\n\n1. History and\u002For physical examination evidence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, immunological, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk for taking part in the trial, influence the results of the trial, influence the participant's ability to take part in the trial.\n2. Any medication (including vaccines, over the counter (OTC) and\u002For prescription medication, dietary supplements, nutraceuticals, vitamins and\u002For herbal supplements, and hormonal replacement therapy for postmenopausal participants) for 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first administration of trial drug (except occasional paracetamol (maximum dose of 2 g\u002Fday and maximum of 10 g\u002F2 weeks).\n3. History of chronic drug or alcohol abuse (defined as an average intake of more than 21 units of alcohol per week for males and 14 for females. 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) in the last 2 years.",true,"ALL","18 Years","55 Years",{"count":78,"type":79},88,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.",[85],"Healthy Participants","2026-06-22",{"date":88,"type":89},"2026-06-23","ACTUAL",{"date":91,"type":89},"2025-06-18",{"date":93,"type":79},"2026-11",{"name":5,"class":6},1]