[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xalud Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"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":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"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",[27],"Amyotrophic Lateral Sclerosis (ALS)","NOT_YET_RECRUITING","2026-07-28",{"date":31,"type":32},"2026-07-29","ACTUAL",{"date":34,"type":21},"2027-03",{"date":36,"type":21},"2028-06",{"name":38,"class":39},"Xalud Therapeutics, Inc.","INDUSTRY",4,""]