[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656776":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":71,"studyPopulation":71,"armGroups":78,"interventions":93,"overallOfficials":71,"centralContacts":99,"locations":105,"responsibleParty":133,"collaborators":71,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":71,"studyType":149,"phases":150,"briefSummary":153,"conditions":154,"keywords":71,"overallStatus":108,"whyStopped":71,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Kriya Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":71},[9,13,17,19,21,23],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, and abnormal vital signs","Safety of VV-14300","52 Weeks",{"measure":14,"description":15,"timeFrame":16},"Change from Baseline in blood glucose by as measured by continuous glucose monitoring (CGM)","Efficacy of VV-14300 (Part 1)","8 Weeks",{"measure":18,"description":15,"timeFrame":16},"Change from Baseline in blood glucose as measured by hemoglobin A1c (HbA1c) level",{"measure":20,"description":15,"timeFrame":16},"Change from Baseline in blood glucose as measured by fructosamine level",{"measure":22,"description":15,"timeFrame":16},"Change from Baseline in blood glucose as measured by mixed meal tolerance test (MMTT)",{"measure":24,"description":25,"timeFrame":26},"Mean change from Baseline in HbA1c","Efficacy of VV-14300 (Part 2)","26 Weeks",[28,31,33,35,37,39,41,43,45,48,50,52,54,58,60,62,65,68],{"measure":24,"description":29,"timeFrame":30},"Efficacy of VV-14300","16, 26 (Part 1), and 52 Weeks",{"measure":32,"description":29,"timeFrame":12},"Change from Baseline in glucose time-in-range derived from CGM data",{"measure":34,"description":29,"timeFrame":12},"Change from Baseline in mean glucose concentration derived from CGM data",{"measure":36,"description":29,"timeFrame":12},"Change from Baseline in Glucose Management Indicator (GMI) derived from CGM data",{"measure":38,"description":29,"timeFrame":12},"Change from Baseline in glycemic variability (coefficient of variation) derived from CGM data",{"measure":40,"description":29,"timeFrame":12},"Change from Baseline in total daily insulin dose (basal and bolus)",{"measure":42,"description":29,"timeFrame":12},"Change from Baseline in blood glucose by mixed meal tolerance test (MMTT)",{"measure":44,"description":29,"timeFrame":12},"Change from Baseline in blood glucose by fructosamine level",{"measure":46,"description":47,"timeFrame":12},"Change from Baseline in Diabetes Medication Satisfaction Tool (DMSAT) score","Patient-reported outcomes for VV-14300",{"measure":49,"description":47,"timeFrame":12},"Change from Baseline in 8-item Type 1-Diabetes Distress Assessment System (T1-DDAS) Core Scale score",{"measure":51,"description":47,"timeFrame":12},"Change from Baseline in Wellbeing Index (WHO-5 questionnaire) score",{"measure":53,"description":47,"timeFrame":12},"Change from Baseline in Hypoglycemia Fear Survey-II Short Form (HFS-II-SF) score",{"measure":55,"description":56,"timeFrame":57},"Change from Baseline in quality-of-life measures as assessed by qualitative interviews","Identification of key quality-of-life themes using semi-structured qualitative interviews to assess patient experiences with the disease and treatment","52 weeks",{"measure":59,"description":11,"timeFrame":12},"Change from Baseline in body weight",{"measure":61,"description":11,"timeFrame":12},"Change from Baseline in fasting lipid levels",{"measure":63,"description":64,"timeFrame":12},"Change from Baseline in the level of antibodies to AAV vector capsid and VV-14300-expressed transgene product by enzyme-linked immunosorbent assay (ELISA)","Humoral immune response to VV-14300",{"measure":66,"description":67,"timeFrame":12},"Change from Baseline in interferon-gamma cellular immune response to AAV1 capsid and VV-14300-expressed transgene product by enzyme-linked immunosorbent spot (ELISpot) assay","Cellular immune response to VV-14300",{"measure":69,"description":70,"timeFrame":12},"VV-14300 vector levels in biological samples","Vector shedding of VV-14300 in serum, nasal mucus, urine, semen, feces, saliva (Part 1)",null,{"allocation":73,"interventionModel":74,"interventionModelDescription":71,"primaryPurpose":75,"observationalModel":71,"timePerspective":71,"maskingInfo":76},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":77,"maskingDescription":71,"whoMasked":71},"NONE",[79,85,89],{"label":80,"type":81,"description":82,"interventionNames":83},"Part 1 - Low dose","EXPERIMENTAL","VV-14300 (low dose) will be administered via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300 dosing to reduce the risk of immune responses.",[84],"Genetic: VV-14300",{"label":86,"type":81,"description":87,"interventionNames":88},"Part 1 - High dose","VV-14300 (high dose) will be administered via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300 dosing to reduce the risk of immune responses.",[84],{"label":90,"type":81,"description":91,"interventionNames":92},"Part 2 - Dose Expansion","A single dose of VV-14300 at the dose selected from Part 1 will be administered via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300 dosing to reduce the risk of immune responses.",[84],[94],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":71},"GENETIC","VV-14300","VV-14300 will be administered via ultrasound-guided intramuscular injections",[86,80,90],[100],{"name":101,"role":102,"phone":103,"phoneExt":71,"email":104},"VP, Medical Affairs","CONTACT","984-884-5058","clinicaltrials@kriyatx.com",[106,121],{"facility":107,"status":108,"city":109,"state":71,"zip":71,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"Kriya Clinical Trial Site","RECRUITING","Toronto","Canada","CA",{"type":113,"coordinates":114},"Point",[115,116],-79.39864,43.70643,{"lat":116,"lon":115},[119],{"name":101,"role":102,"phone":120,"phoneExt":71,"email":104},"1-984-884-5058",{"facility":107,"status":122,"city":123,"state":71,"zip":71,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"NOT_YET_RECRUITING","Christchurch","New Zealand","NZ",{"type":113,"coordinates":127},[128,129],172.63333,-43.53333,{"lat":129,"lon":128},[132],{"name":101,"role":102,"phone":120,"phoneExt":71,"email":104},{"type":134,"investigatorFullName":71,"investigatorTitle":71,"investigatorAffiliation":71,"oldNameTitle":71,"oldOrganization":71},"SPONSOR","100656776","phase-1-vv-14300-for-the-treatment-of-type-1-diabetes-100656776",false,"NCT07831798","VV-14300 for the Treatment of Type 1 Diabetes","A Phase 1\u002F2, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of VV-14300 (Adeno-associated Virus Vector-mediated Glucokinase) in Adults With Long-Standing Type 1 Diabetes and Suboptimal Glycemic Control Using an Automated Insulin Delivery (AID) System","RELIEVE","Inclusion Criteria:\n\n* Able to provide signed informed consent.\n* 18 to 65 years of age (inclusive) at Screening.\n* Body mass index (BMI) of 20.0 to \\\u003C30.0 kg\u002Fm².\n* Clinical diagnosis of Type 1 Diabetes for at least 5 years prior to Screening, currently managed with an Automated Insulin Delivery (AID) system for at least 3 months prior to Screening.\n* Suboptimal glycemic control (HbA1c \\>7% and \\\u003C10%), and on a stable insulin regimen at Screening.\n* Adequate kidney function (estimated glomerular filtration rate \\[eGFR\\] \\>60 mL\u002Fmin\u002F1.73m²) at Screening.\n* Females of child-bearing potential must have a negative pregnancy test at Screening and prior to dosing; participants must agree to use highly effective contraception during and for at least 12 months after study intervention administration.\n* Agree to refrain from donating blood, plasma, platelets, eggs, or sperm during the 12-month Post-Treatment Follow-up Period.\n* Willing and able to complete all study visits, procedures, and required use of study-provided monitoring devices for the duration of the study.\n\nExclusion Criteria:\n\n* Type 2 diabetes or other condition requiring exogenous insulin that is not due to autoimmunity, or when insulin delivery is not managed through an AID system.\n* Diabetic complications (e.g., severe\u002Fproliferative retinopathy or neuropathy) or a clinically significant medical, cognitive, or psychiatric condition that, in the Investigator's opinion, poses additional risk or would make consistent study follow-up unlikely.\n* Recurrent diabetic ketoacidosis (2 or more events in the 12 months prior to Screening).\n* Pregnant or breastfeeding.\n* History of malignancy requiring chemotherapy and\u002For radiation within the 12 months prior to Screening, except for successfully treated non-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia, and localized prostate cancer.\n* Clinically significant cardiovascular or cerebrovascular disease, uncontrolled blood pressure, family history of Long QT syndrome, or clinically significant ECG abnormality.\n* Significant history of alcohol or drug abuse, or positive alcohol breath test or urine drug screen at the Screening or Run-in visit.\n* Plans to implement new strenuous physical activity (e.g., significantly increased running pace\u002Fduration, high-intensity interval training, heavy weightlifting, vigorous cycling) during the study.\n* Impaired awareness of hypoglycemia.\n* Active hepatitis B or C infection, positive HIV serology, or any latent or active infection that would interfere with study procedures or be exacerbated by study medications.\n* Clinically significant abnormal Screening laboratory or other diagnostic findings (including hepatic, hematologic, thyroid, muscle-enzyme, or tuberculosis screening) rendering the participant unsuitable for the study.\n* Current or recent use of medications that could interfere with glucose metabolism or confound study assessments (e.g., glucocorticoids, systemic beta-blockers, growth hormone, or other antidiabetic medications \\[e.g., glucagon-like peptide 1 (GLP-1) receptor agonists and\u002For sodium-glucose cotransport 2 (SGLT2) inhibitors\\]).\n* Vaccination within 30 days prior to dosing or planned vaccination within 8 weeks post-dosing.\n* Known hypersensitivity to tocilizumab, or Screening laboratory findings indicating undue risk of a tocilizumab-related adverse event.\n* History of bariatric surgery within the 12 months prior to Screening.\n* History of trauma to, or other findings affecting the suitability of, the muscles intended for study intervention administration.\n* Participation in another investigational drug or biologic trial within 6 months prior to Screening, or participation in any previous gene therapy trial","ALL","18 Years","65 Years",{"count":147,"type":148},29,"ESTIMATED","INTERVENTIONAL",[151,152],"PHASE1","PHASE2","This study is testing VV-14300 in adults with long-standing type 1 diabetes (T1D) whose blood sugar is not well controlled despite using an automated insulin delivery (AID) system. VV-14300 is an investigational gene therapy that is injected into muscle and is designed to help remove excess sugar from the blood.",[155],"Type 1 Diabetes Mellitus","2026-10-02",{"date":158,"type":159},"2026-10-05","ACTUAL",{"date":161,"type":148},"2026-10",{"date":163,"type":148},"2028-11",{"name":5,"class":6},2]