[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Leal Therapeutics, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100649302","phase-1-a-study-of-ltx-001-in-adult-participants-with-acute-exacerbation-of-schizophrenia-100649302",false,"NCT07734493","A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia","A Phase 1b, Multicenter, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Early Signs of Efficacy of Orally Administered LTX-001 As Monotherapy in Adult Participants With Acute Exacerbation of Schizophrenia","Inclusion Criteria:\n\n* BMI \\> 17.5 and \\\u003C 38.0 kg\u002Fm2 and a total body weight \\> 50.0 kg (110 lbs)\n* Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR)\n* Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study\n* PANSS total score ≥ 80 at the time of screening for the study\n* Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period\n* Sexually active adults must be willing to use an acceptable contraceptive method throughout the study\n\nExclusion Criteria:\n\n* Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination\n* History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine\n* Current DSM-5-TR diagnosis other than schizophrenia\n* Pregnant or lactating female\n* Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening\n* Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening\n* Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening","ALL","18 Years","55 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this clinical trial is to learn whether the investigational drug LTX-001 is safe and well tolerated in adults with a diagnosis of schizophrenia who are having a recent worsening of their symptoms (an acute exacerbation). Additional questions it aims to answer are:\n\n* how does the amount of the study drug in the body change over time (pharmacokinetics)\n* how does the study drug affect the symptoms of schizophrenia\n* how do certain markers in the blood change after administration of LTX-001 (pharmacodynamics)\n\nResearchers will compare different dose levels of LTX-001 to an inactive product (placebo) to see what differences there are between the two treatments.\n\nAfter successfully screening for the study, participants will stay in a research unit for about five weeks and return one week later for a follow-up visit.",[27],"Schizophrenia",[29],"schizophrenia","RECRUITING","2026-08-19",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":21},"2026-08",{"date":38,"type":21},"2027-03",{"name":40,"class":41},"Leal Therapeutics, Inc","INDUSTRY",10,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100641756","phase-1-a-study-of-ltx-002-in-adult-participants-with-amyotrophic-lateral-sclerosis-100641756","NCT07660614","A Study of LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis","A First-in-Human, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intrathecally Administered LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis","NeurALS","Inclusion Criteria:\n\n* Diagnosis of ALS per Gold Coast criteria\n* ALS symptom onset less than 36 months prior to Screening\n* Slow vital capacity ≥ 50% of predicted value\n* Body mass index ≥18 and ≤40 kg\u002Fm2\n\nExclusion Criteria:\n\n* Current evidence or history of a clinically significant medical condition that, in the Investigator's judgement, would impact the participant's safety, interpretation of study results, or place the participant at high risk of poor treatment compliance or of not completing the study\n* History of brain or spinal abnormalities on magnetic imaging (MRI) or computed tomography (CT) that might interfere with the lumbar puncture (LP), cerebrospinal fluid (CSF) circulation or safety assessments\n* Prior treatment with antisense oligonucleotide (ASO), small interfering RNA, stem cell therapy, or gene therapy for any indication\n* Tracheostomy\n* HIV, Hepatitis B or C infection (acute or chronic)\n* Presence of implanted shunt (CSF) or vascular device\n* Risk for uncontrolled bleeding\n* Pregnant or breastfeeding","75 Years",{"count":53,"type":21},56,[24,55],"PHASE2","This study will examine what happens when patients with amyotrophic lateral sclerosis (ALS) are given an investigational medication (study drug) known as LTX-002. Specifically, the researchers will be looking at safety, tolerability (if someone has any side effects from the drug), pharmacokinetics (what the body does to the study drug) and pharmacodynamics (what the study drug does to the body). The study will also investigate the effect of the drug on indicators of the severity of ALS, such as markers in blood and in the cerebrospinal fluid (the fluid that surrounds the brain and spinal cord, CSF) and on measures of the participant's ability to move, speak, and breathe.",[58],"Amyotrophic Lateral Sclerosis",[60],"ALS","2026-08-17",{"date":63,"type":34},"2026-08-18",{"date":65,"type":34},"2026-04-29",{"date":67,"type":21},"2031-06",{"name":40,"class":41},5,""]