[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611927":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":39,"locations":47,"responsibleParty":111,"collaborators":30,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":30,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":30,"overallStatus":50,"whyStopped":30,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: RG6496","EXPERIMENTAL","Participants will receive single dose of RG6496. Participants will be enrolled in planned sequential cohorts associated with ascending dose levels.",[13],"Drug: RG6496",{"label":15,"type":16,"description":17,"interventionNames":18},"Part 1: Placebo","PLACEBO_COMPARATOR","Participants will receive a single dose of RG6496 matching placebo.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Part 2: OLE","All participants who have completed Part 1 and are eligible for Part 2 will receive one open-label dose of RG6496.",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","RG6496","RG6496 will be administered as per the schedule specified in the respective arms.",[9,21],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Placebo","RG6496 matching placebo will be administered as per the schedule specified in placebo arm.",[15],[36],{"name":37,"affiliation":5,"role":38},"Clinical Trials","STUDY_DIRECTOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Reference Study ID Number: BP45378 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":46,"role":42,"phone":30,"phoneExt":30,"email":30},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[48,55,68,79,88,99],{"facility":49,"status":50,"city":51,"state":30,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Hospital Britanico de Buenos Aires","RECRUITING","Ciudad Autonoma Bs As","C1280AEB","Argentina","AR",{"facility":56,"status":50,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":30},"Westmead Hospital","Westmead","New South Wales","2145","Australia","AU",{"type":63,"coordinates":64},"Point",[65,66],150.98768,-33.80383,{"lat":66,"lon":65},{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":60,"countryCode":61,"cosmosGeoPoint":74,"geoPoint":78,"contacts":30},"Monash Health","SUSPENDED","Clayton","Victoria","3168",{"type":63,"coordinates":75},[76,77],145.11667,-37.91667,{"lat":77,"lon":76},{"facility":80,"status":50,"city":81,"state":72,"zip":82,"country":60,"countryCode":61,"cosmosGeoPoint":83,"geoPoint":87,"contacts":30},"Royal Melbourne Hospital","Parkville","3050",{"type":63,"coordinates":84},[85,86],144.95,-37.78333,{"lat":86,"lon":85},{"facility":89,"status":50,"city":90,"state":30,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":98,"contacts":30},"New Zealand Brain Research Institute","Christchurch","8011","New Zealand","NZ",{"type":63,"coordinates":95},[96,97],172.63333,-43.53333,{"lat":97,"lon":96},{"facility":100,"status":50,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":30},"Cambridge Centre for Brain Repair","Cambridge","Cambridgeshire","CB2 0PY","United Kingdom","UK",{"type":63,"coordinates":107},[108,109],0.11667,52.2,{"lat":109,"lon":108},{"type":112,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100611927","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-rg6496-in-huntingtons-disease-100611927",false,"NCT07246941","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in Huntington's Disease","A Phase I, 2-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-ascending Doses of Intrathecally Administered RG6496 in a Randomized, Placebo-controlled, Investigator\u002FParticipant-blind Study With an Open-label Extension in Huntington's Disease Gene Expansion Carriers","POINT-HD","Inclusion Criteria:\n\nPart 1\n\n* Confirmation of HDGEC status with cytosine-adenine-guanine (CAG) expansion \\> 39.\n* Confirmation of SNP carrier status of the target SNP\n* Independence Scale (IS) score of ≥70, total functional capacity (TFC) ≥10, total motor score (TMS) \\>6.\n* Ability to read the words \"red,\" \"blue,\" and \"green\" and be fluent in the language of the informed consent form (ICF) and the tests used at the study site.\n* Ability to walk unassisted.\n* Total body weight \\> 40 kilogram (kg) and body mass index (BMI) within the range 18-32 kilogram per square meter (kg\u002Fm\\^2) (inclusive) at baseline.\n* Ability to undergo and tolerate MRI scans.\n\nPart 2\n\n* Completed the post-dose safety follow-up period in the Part 1 of the study.\n* In the opinion of the Investigator, the participant has not experienced a worsening in health that precludes their safe continued participation in the study.\n\nExclusion Criteria:\n\nPart 1\n\n* Concurrent or planned participation in any interventional clinical study, including current use of an ASO or any HTT-lowering therapy or treatment with investigational therapy within 90 days or 5 drug-elimination half-lives, whichever is longer prior to screening\n* Pregnant or breastfeeding, or with the intention of becoming pregnant during the study or within the timeframe in which contraception is required\n* Malignancy within 5 years prior to screening\n* Planned brain surgery during the study\n* Positive HIV test, hepatitis B surface antigen and hepatitis B surface antigen at screening\n* Active psychosis, confusional state, or violent behavior, including aggression that could cause harm to self or others, over the 12 weeks prior to screening.\n* Current or previous history of a primary independent psychotic disorder.\n* Scoliosis or spinal deformity or surgery making IT injection not feasible in an outpatient setting\n* History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and\u002For change in level of care within 12 months prior to screening.\n\nPart 2\n\n* Prematurely discontinued from Part 1 for any reason (i.e., before the completion of the postdose safety follow-up period of Part 1).\n* Pregnant or breastfeeding, or with the intention of becoming pregnant during the study or within the timeframe in which contraception is required.\n* Concurrent or planned participation in any interventional clinical study, including current use of an ASO or any HTT-lowering therapy\n* Received any active investigational treatment other than RG6496 during or since completion of Part 1 of the study.\n* Had confirmed Dose-Limiting Adverse Event (DLAE)(s) in Part 1 of the study.","ALL","25 Years","65 Years",{"count":125,"type":126},40,"ESTIMATED","INTERVENTIONAL",[129],"PHASE1","This is a first-in-human (FIH) study of RG6496 that will assess the safety and tolerability of single-ascending doses of RG6496 administered to huntington's disease gene expansion carriers (HDGECs). The study consists of two parts: Part 1 \\[single-ascending dose\\] followed by Part 2 \\[open-label extension (OLE)\\].",[132],"Huntington's Disease","2026-06-26",{"date":135,"type":136},"2026-06-29","ACTUAL",{"date":138,"type":136},"2025-11-19",{"date":140,"type":126},"2029-05-23",{"name":5,"class":6},6]