[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624013":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":41,"centralContacts":47,"locations":53,"responsibleParty":65,"collaborators":41,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":41,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":41,"overallStatus":88,"whyStopped":41,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Kriya Therapeutics, Inc.","INDUSTRY",[8,14,18,22,26,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 Cohort 1, low dose","EXPERIMENTAL","A single low dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.",[13],"Genetic: VV-14305",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1 Cohort 2, mid dose","A single mid dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 1 Cohort 3, high dose","A single high dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part 1 Optional Cohort 4, Part 2 dose","A single dose of VV-14305 determined from Cohorts 1, 2, and 3 will be administered. In addition, prednisone will be administered prior to and after VV-14305.",[13],{"label":27,"type":10,"description":24,"interventionNames":28},"Part 2 Treatment Arm",[13],{"label":30,"type":31,"description":32,"interventionNames":33},"Part 2 Sham Arm","SHAM_COMPARATOR","A single sham injection will be administered. In addition, prednisone will be administered prior to and after the sham injection.",[34],"Other: Sham (No Treatment)",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"GENETIC","VV-14305","VV-14305 will be administered via peribulbar injection.",[9,15,19,23,27],null,{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":41},"OTHER","Sham (No Treatment)","Sham solution such as Saline",[30],[48],{"name":49,"role":50,"phone":51,"phoneExt":41,"email":52},"VP, Medical Affairs","CONTACT","984.884.5058","clinicaltrials@kriyatx.com",[54],{"facility":55,"status":41,"city":56,"state":57,"zip":41,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":41},"Kriya Clinical Trial Site","Auckland","New Zealand","NZ",{"type":60,"coordinates":61},"Point",[62,63],174.76349,-36.84853,{"lat":63,"lon":62},{"type":66,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100624013","phase-1-a-study-of-vv-14305-for-the-treatment-of-thyroid-eye-disease-100624013",false,"NCT07404111","A Study of VV-14305 for the Treatment of Thyroid Eye Disease","An Adaptive Phase 1\u002F2 MulticenteR Study Evaluating the Safety, Tolerability, Pharmacokinetics and EfficaCy of VV-14305 Delivered Via PeribuLbAr Injection in Patients With Moderate to Severe Thyroid Eye Disease (the RECLAIM Study)","RECLAIM","Inclusion Criteria:\n\n1. Must be 18 to 80 years of age (inclusive) at Screening.\n2. Body Mass Index (BMI) of 19 to 34 kg\u002Fm2 (inclusive).\n3. Must be euthyroid (defined as normal thyroid-stimulating hormone) or have mild hyper- or hypothyroidism (being managed to bring them to a euthyroid state).\n4. Best Corrected Visual Acuity (BCVA) score of 20\u002F60 or better at Screening with no history of deterioration noted in the 3 months prior to Screening.\n5. Must be willing and able to cease product use prior to VV-14305 (or sham) peribulbar injection if using non-steroidal anti-inflammatory drug (NSAIDs), medications or any herbal supplements, vitamins, or multivitamins with antiplatelet\u002Fanticoagulant properties.\n6. The study eye and the fellow eye must fall within the pre-defined degree of proptosis and clinical activity score (CAS) as measured at Screening.\n7. Participants must be diagnosed with TED prior to Screening and be diagnosed with Graves' disease and progressive moderate to severe TED at Screening.\n\nExclusion Criteria:\n\n1. History of serious ocular condition(s) other than TED, including but not limited to uveitis, dry age-related macular degeneration (AMD), and wet AMD; Other orbital or ophthalmic diseases, including inflammatory conditions, optic neuropathy, tumors, glaucoma with visual field defect or visual field loss, that in the opinion of the Investigator and\u002For Medical Monitor is clinically significant.\n2. Any medical, cognitive, or psychiatric condition that, in the opinion of the Investigator, could contraindicate the use of the investigational drug, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or would make the participant an unsafe study candidate.\n3. Diagnosed with diabetes (HbA1c ≥6.5%).\n4. History of malignancy requiring chemotherapy and\u002For radiation in the 12 months prior to Screening, except for successfully treated nonmelanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia, and localized prostate cancer.\n5. Known allergy or condition that would contraindicate the use of required study medications.\n6. Any Screening assessment or laboratory value that, in the opinion of the Investigator and\u002For Medical Monitor, is clinically significant and renders the subject not suitable for study participation.\n7. Any vaccination or planned vaccination 30 days prior to dosing, 4 weeks post dosing or during period of immunosuppression.\n8. Participant requires or, in the opinion of the Investigator, is likely to require immediate surgical ophthalmological\u002Forbital intervention or irradiation of either eye; Has had any prior surgery for TED including orbital decompression, strabismus surgery and any eyelid surgery on either eye.\n9. Prior participation in other gene therapy, investigational drug, biologic or device clinical trials within 30 days prior to Screening.","ALL","18 Years","80 Years",{"count":79,"type":80},110,"ESTIMATED","INTERVENTIONAL",[83,84],"PHASE1","PHASE2","The goal of this study is to evaluate the safety, tolerability, and efficacy of KRIYA-586 (VV-14305) in treating thyroid eye disease (TED).",[87],"Thyroid Eye Disease (TED)","NOT_YET_RECRUITING","2026-02-04",{"date":91,"type":92},"2026-02-11","ACTUAL",{"date":94,"type":80},"2026-02",{"date":96,"type":80},"2029-02",{"name":5,"class":6},1]