[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623783":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":42,"collaborators":44,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Celosia Therapeutics Pty Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Active drug-CTx1000","EXPERIMENTAL","All participants will receive only one dose of the study drug",[13],"Drug: AAV9 Gene therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","AAV9 Gene therapy","Single dose gene therapy",[9],null,[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Macquarie University Hospital","RECRUITING","Sydney","New South Wales","2109","Australia","AU",{"type":31,"coordinates":32},"Point",[33,34],151.20732,-33.86785,{"lat":34,"lon":33},[37],{"name":38,"role":39,"phone":40,"phoneExt":20,"email":41},"Richard Gan","CONTACT","61298123739","richard.gan@mq.edu.au",{"type":43,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[45],{"name":46,"class":6},"Novotech (Australia) Pty Limited","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":59,"type":60},15,"ESTIMATED","INTERVENTIONAL",[63],"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.",[66],"ALS (Amyotrophic Lateral Sclerosis)",[68,69,70,71,72],"CTx1000","gene therapy","motor neuron disease","genetic medicine","Lou Gehrig disease","2026-02-06",{"date":75,"type":76},"2026-02-10","ACTUAL",{"date":78,"type":76},"2026-01-12",{"date":80,"type":60},"2030-12",{"name":5,"class":6},1]