[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570215":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":24,"locations":30,"responsibleParty":100,"collaborators":23,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":23,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":23,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":23,"overallStatus":121,"whyStopped":23,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Xalud Therapeutics, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: 1.5 mg XT-150","EXPERIMENTAL","Participants will be administered 1.5 mg of XT-150 once by intrathecal injection on Day 1. An intrathecal injection is an injection using a thin needle inserted into the spinal canal at the base of your spinal cord performed by your study doctor.",[13],"Biological: XT-150",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 2: 4.5 mg XT-150",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"BIOLOGICAL","XT-150","XT-150 is a small piece of plasmid DNA (genetic material) that produces a variant of the anti-inflammatory cytokine, Interleukin 10 (IL-10).",[9,15],null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Director of Medical Information","CONTACT","212-301-6673","medical.information@xaludthera.com",[31,44,62,79],{"facility":32,"status":23,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":23},"Barrow Neurological Institute (St. Joseph's)","Phoenix","Arizona","85013","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-112.07404,33.44838,{"lat":42,"lon":41},{"facility":45,"status":23,"city":46,"state":47,"zip":48,"country":36,"countryCode":37,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"Johns Hopkins University","Baltimore","Maryland","21205",{"type":39,"coordinates":50},[51,52],-76.61219,39.29038,{"lat":52,"lon":51},[55,59],{"name":56,"role":27,"phone":57,"phoneExt":23,"email":58},"Betsy Mosmiller, Sr. Research Program Manager","410-502-0495","emosmil1@jhmi.edu",{"name":60,"role":61,"phone":23,"phoneExt":23,"email":23},"Jeffrey Rothstein, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":23,"city":64,"state":65,"zip":66,"country":36,"countryCode":37,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":39,"coordinates":68},[69,70],-71.05977,42.35843,{"lat":70,"lon":69},[73,77],{"name":74,"role":27,"phone":75,"phoneExt":23,"email":76},"Shyanne Hill","617-643-5376","mghxaludphase1@mgb.org",{"name":78,"role":61,"phone":23,"phoneExt":23,"email":23},"Sabrina Paganoni, MD",{"facility":80,"status":23,"city":81,"state":82,"zip":83,"country":36,"countryCode":37,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Henry Ford Health","Detroit","Michigan","48202",{"type":39,"coordinates":85},[86,87],-83.04575,42.33143,{"lat":87,"lon":86},[90,94,98],{"name":91,"role":27,"phone":92,"phoneExt":23,"email":93},"Maria Stotland, RN, CRC","313-916-3359","mstotla1@hfhs.org",{"name":95,"role":27,"phone":96,"phoneExt":23,"email":97},"Anne Vallis, BS, MA, CRC","313-916-1364","Avallis1@hfhs.org",{"name":99,"role":61,"phone":23,"phoneExt":23,"email":23},"Ximena Arcila-Londono, MD",{"type":101,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100570215","phase-1-safety-study-of-xt-150-in-participants-with-als-100570215",false,"NCT06704347","Safety Study of XT-150 in Participants With ALS","A Phase 1, Open-Label Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Single Ascending Dose Regimens of XT-150 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)","Key Inclusion Criteria:\n\n* Adults between 18 and 80 years of age\n* Male or female, if of childbearing potential or sexually active, strict contraception required\n* Have ALS diagnosed by a doctor (specifically, sporadic or familial ALS diagnosed as clinically probable, lab-supported probable or definite ALS defined by the El Escorial criteria)\n* Have had symptoms of ALS (muscle weakness) within 36 months of starting this study\n* Have the ability to slowly exhale a volume of air at least 60% of what is expected for the participant's sex, height and age\n* Have not received treatment for ALS or are currently on a stable dose of an approved treatment for ALS. Patients currently receiving Tofersen are not eligible.\n* Able to receive the study injection intrathecally, determined by the study doctor\n* Able to undergo the study procedures and adhere to the study visit schedule at the time of study entry, with an estimated life expectancy of 6 months or greater\n\nKey Exclusion Criteria:\n\n* Have an implanted shunt to drain cerebrospinal fluid (CSF) or an implanted CNS catheter\n* Have an implanted of diaphragm pacing system\n* Tracheostomy\n* History or current diagnosis of cardiac conditions or ECG abnormalities indicating significant risk of safety for participants in the study\n* History or current diagnosis of respiratory conditions such as COPD\n* History or current diagnosis of cancer, chemical meningitis, HIV, Hep B, Hep C, uncontrolled diabetes\n* Presence of an autoimmune condition (for example, rheumatoid arthritis or lupus) requiring treatment or immunodeficiency\n* Clinical or laboratory evidence of hepatic or renal disease\u002Finjury.\n* Taking any prohibited medications\n* Women who are pregnant or nursing\n* Use of any investigational drugs or devices within 30 days or 5 half-lives of the study agent (whichever is longer). Exception: Observational, non-interventional clinical studies are allowed in the opinion of the study doctor.\n* Any other condition that the study doctor feels could compromise the participant's safety, ability to communicate with the study staff, or the quality of the data","ALL","18 Years","80 Years",{"count":113,"type":114},8,"ESTIMATED","INTERVENTIONAL",[117],"PHASE1","This is a Phase 1, open-label, multi-center safety study of XT-150 in adult participants with Amyotrophic Lateral Sclerosis (ALS).\n\nParticipants providing informed consent and meeting all study eligibility criteria will be enrolled in the study and will receive a single injection of XT-150 at the Baseline visit. Follow-up visits will occur over 180 days (6 months) after the injection.\n\n8 participants (4 participants per dose level) will be enrolled sequentially in up to 2 ascending, single dose cohorts: Cohort 1: 1.5 mg XT-150 Cohort 2: 4.5 mg XT-150",[120],"Amyotrophic Lateral Sclerosis (ALS)","NOT_YET_RECRUITING","2026-07-28",{"date":124,"type":125},"2026-07-29","ACTUAL",{"date":127,"type":114},"2027-03",{"date":129,"type":114},"2028-06",{"name":5,"class":6},4]