[{"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:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"ALS (Amyotrophic Lateral Sclerosis)",[29,30,31,32,33],"CTx1000","gene therapy","motor neuron disease","genetic medicine","Lou Gehrig disease","RECRUITING","2026-02-06",{"date":37,"type":38},"2026-02-10","ACTUAL",{"date":40,"type":38},"2026-01-12",{"date":42,"type":21},"2030-12",{"name":44,"class":45},"Celosia Therapeutics Pty Ltd","INDUSTRY",""]