[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neurosterix\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"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":21,"type":22},73,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Healthy Participants","Schizophrenia Diagnosis",[31,32,33,34,35,36,37,38],"Phase 1","Healthy volunteer","Schizophrenia","Pharmacokinetics","Single ascending dose","Multiple ascending dose","Food effect","Safety","RECRUITING","2026-01-07",{"date":42,"type":43},"2026-01-15","ACTUAL",{"date":45,"type":43},"2025-10-03",{"date":47,"type":22},"2026-05",{"name":49,"class":50},"Neurosterix","INDUSTRY",""]