[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619463":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":42,"centralContacts":46,"locations":55,"responsibleParty":75,"collaborators":37,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":37,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":37,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":58,"whyStopped":37,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Neurosterix","INDUSTRY",[8,14,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"NTX-253 Part 1a","EXPERIMENTAL","Participants will be assigned to receive one of multiple single ascending daily oral doses of NTX-253",[13],"Drug: NTX-253",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo Part 1a","Participants will be assigned to receive one of multiple single ascending daily oral doses of placebo",[18],"Drug: Placebo",{"label":20,"type":10,"description":21,"interventionNames":22},"NTX-253 Part 1b","Participants will receive the maximum tolerated single oral dose of NTX-253",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"NTX-253 Part 2","Participants will be assigned to receive one of multiple ascending oral daily doses of NTX-253 for 10 days",[13],{"label":28,"type":10,"description":29,"interventionNames":30},"Placebo Part 2","Participants will be assigned to receive one of multiple ascending daily oral doses of placebo for 10 days",[18],[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","NTX-253","Oral Capsule",[9,20,24],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Placebo","Oral capsule",[15,28],[43],{"name":44,"affiliation":5,"role":45},"Doug Feltner, MD","STUDY_DIRECTOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":37,"email":51},"Doug Feltner, Chief Medical Officer, MD","CONTACT","+41 22 884 15 55","doug.feltner@neurosterix.com",{"name":53,"role":49,"phone":50,"phoneExt":37,"email":54},"Lisa Corey","lisa.corey@neurosterix.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Collaborative Neuroscience Research, LLC - CenExel","RECRUITING","Los Alamitos","California","90720","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-118.07256,33.80307,{"lat":68,"lon":67},[71],{"name":72,"role":49,"phone":73,"phoneExt":37,"email":74},"Recruitment","866-787-4257","alamitors.info@CenExel.com",{"type":76,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100619463","early-phase-1-single-and-multiple-ascending-doses-of-ntx-253-in-healthy-participants-and-participants-with-stable-schizophrenia-100619463",false,"NCT07344948","Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia","A First in Human, Phase 1\u002F1b Study of Single and Multiple Ascending Dosing Administration of NTX110253 in Healthy Participants and Participants With Stable Schizophrenia","Primary Inclusion Criteria:\n\n* Male or non-pregnant, non-lactating female participants, ages 18-55 who are not of childbearing potential, with a truly abstinent lifestyle, or agrees to use medically acceptable forms of birth control\n* Part 1 a\u002Fb, Part 2 Cohort 7 only: Body mass index (BMI) within the range ≥18.0 to ≤30.0 kg\u002Fm2\n* Participants in the food effect cohort must be willing to eat a single high fat breakfast\n* (Part 2 only): Stable schizophrenia participants (schizophrenia cohorts only)\n* Body mass index (BMI) within the range ≥17.5 to ≤36.0 kg\u002Fm2\n* Positive and Negative Syndrome Scale (PANSS) total score \\\u003C80 at screening\n\nPrimary Exclusion Criteria:\n\n* (Part 1a\u002Fb, Part 2 Healthy): History of or current clinically significant medical or mental illness\n* Cancer diagnosis\u002Ftreatment in the past 7 years\n* Acute or chronic gastrointestinal conditions that would interfere with drug tolerance or absorption\n* Any clinically significant, abnormal 12 lead ECG\n* Part 2: Any primary DSM-5TR disorder other than schizophrenia\n* Participants with schizophrenia who are considered resistant\u002Frefractory to antipsychotic treatment by history; history of clozapine use.",true,"ALL","18 Years","55 Years",{"count":89,"type":90},73,"ESTIMATED","INTERVENTIONAL",[93],"EARLY_PHASE1","This study will assess the safety, tolerability, and pharmacokinetics of NTX-253 following oral administration in both healthy adult participants as well as adult participants with stable schizophrenia.",[96,97],"Healthy Participants","Schizophrenia Diagnosis",[99,100,101,102,103,104,105,106],"Phase 1","Healthy volunteer","Schizophrenia","Pharmacokinetics","Single ascending dose","Multiple ascending dose","Food effect","Safety","2026-01-07",{"date":109,"type":110},"2026-01-15","ACTUAL",{"date":112,"type":110},"2025-10-03",{"date":114,"type":90},"2026-05",{"name":5,"class":6},1]