[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Celosia Therapeutics Pty Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100623783","phase-1-safety-and-tolerability-study-of-ctx1000-in-participants-with-amyotrophic-lateral-sclerosis-100623783",false,"NCT07401121","Safety and Tolerability Study of CTx1000 In Participants With Amyotrophic Lateral Sclerosis","Koanewa: A First in Human, Phase 1b, Open-label, Non-randomised, Single Dose Study to Assess the Safety and Tolerability of CTx1000 in Participants Diagnosed With Amyotrophic Lateral Sclerosis","KOANEWA","Inclusion Criteria:\n\n* Diagnosis of ALS in accordance with the revised El Escorial criteria and TRICALS risk score\n* An overall disease duration of ≤ 2 years after the participant's first symptoms\n* No or low circulating anti-AAV9 antibodies (titre ≤ 1:50\n* Stable dosing with a standard of care ALS medication (eg, riluzole and edaravone) and other prescription medications for 30 days prior to Screening\n* Not pregnant or breastfeeding, or willing to cease breastfeeding\n* All participants must use a barrier method of contraception\n\nExclusion Criteria:\n\n* Any participants with genetic forms of ALS, including C9ORF72 repeat carriers, except for TARDBP gene variants, as confirmed by previous clinical history genetic testing\n* Any history of myocardial infarction or stroke within 6 months prior to Screening, or uncontrolled diabetes (HbA1C \\> 9%)\n* Positive test for cytomegalovirus, hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody.\n* Inadequate organ function\n* Any participant with a current open tracheostomy","ALL","18 Years","80 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This clinical study is in participants with Amyotrophic Lateral Sclerosis and is designed to evaluate the safety and tolerability of the gene therapy CTx1000.",[28],"ALS (Amyotrophic Lateral Sclerosis)",[30,31,32,33,34],"CTx1000","gene therapy","motor neuron disease","genetic medicine","Lou Gehrig disease","RECRUITING","2026-02-06",{"date":38,"type":39},"2026-02-10","ACTUAL",{"date":41,"type":39},"2026-01-12",{"date":43,"type":22},"2030-12",{"name":45,"class":46},"Celosia Therapeutics Pty Ltd","INDUSTRY",""]