[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656871":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":67,"studyPopulation":67,"armGroups":74,"interventions":94,"overallOfficials":67,"centralContacts":104,"locations":110,"responsibleParty":125,"collaborators":67,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":129,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":67,"studyType":141,"phases":142,"briefSummary":145,"conditions":146,"keywords":67,"overallStatus":113,"whyStopped":67,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Kriya Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":67},[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-14299 and\u002For VV-14300","52 Weeks",{"measure":14,"description":15,"timeFrame":16},"Change from Baseline in blood glucose as measured by continuous glucose monitoring (CGM)","Efficacy of VV-14299 and\u002For VV-14300 (Part 1)","16 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 levels","Efficacy of VV-14299 and\u002For VV-14300 (Part 2)","26 Weeks",[28,31,33,35,37,39,42,44,46,48,50,52,55,58,61,64],{"measure":24,"description":29,"timeFrame":30},"Efficacy of VV-14299 and\u002For VV-14300","16, 26 (Part 1), and 52 Weeks",{"measure":32,"description":29,"timeFrame":12},"Change from Baseline in 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":41,"timeFrame":12},"Change from Baseline in total daily insulin dose (basal and bolus)","Efficacy of VV-14299 and\u002For VV-14300 (insulin-sparing effect)",{"measure":43,"description":41,"timeFrame":12},"Change from Baseline in average insulin boluses per day",{"measure":45,"description":29,"timeFrame":12},"Change from Baseline in blood glucose by mixed meal tolerance test (MMTT)",{"measure":47,"description":29,"timeFrame":12},"Change from Baseline in blood glucose by fructosamine level",{"measure":49,"description":11,"timeFrame":12},"Change from Baseline in body weight",{"measure":51,"description":11,"timeFrame":12},"Change from Baseline in fasting lipid levels",{"measure":53,"description":54,"timeFrame":12},"Change from Baseline in the level of antibodies to AAV vector capsid, VV-14300-expressed transgene product, and VV-14299-expressed transgene product by enzyme-linked immunosorbent assay (ELISA)","Humoral immune response to VV-14299 and\u002For VV-14300",{"measure":56,"description":57,"timeFrame":12},"Change from Baseline in interferon-gamma cellular immune response to AAV1 capsid, VV-14300-expressed transgene product, and VV-14299-expressed transgene product by enzyme-linked immunosorbent spot (ELISpot) assay","Cellular immune response to VV-14299 and\u002For VV-14300",{"measure":59,"description":60,"timeFrame":12},"VV-14300 vector levels in biological samples","Vector shedding of VV-14300 in serum, nasal mucus, urine, semen, feces, saliva (Part 1)",{"measure":62,"description":63,"timeFrame":12},"VV-14299 vector levels in biological samples","Vector shedding of VV-14299 in serum, nasal mucus, urine, semen, feces, saliva (Part 1)",{"measure":65,"description":66,"timeFrame":12},"VV-14299 protein levels in serum","Vector-mediated transgene expression",null,{"allocation":69,"interventionModel":70,"interventionModelDescription":67,"primaryPurpose":71,"observationalModel":67,"timePerspective":67,"maskingInfo":72},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":73,"maskingDescription":67,"whoMasked":67},"NONE",[75,81,86,90],{"label":76,"type":77,"description":78,"interventionNames":79},"Part 1 - Cohort 1 (VV-14300, single dose)","EXPERIMENTAL","A single dose of VV-14300 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.",[80],"Genetic: VV-14300",{"label":82,"type":77,"description":83,"interventionNames":84},"Part 1 - Cohort 2 (VV-14300, single dose + VV-14299, low dose)","The same dose of VV-14300 from Cohort 1 will be co-administered with VV-14299 (low dose) via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300\u002FVV-14299 dosing to reduce the risk of immune responses.",[80,85],"Genetic: VV-14299",{"label":87,"type":77,"description":88,"interventionNames":89},"Part 1 - Cohort 3 (VV-14300, single dose + VV-14299, high dose)","The same dose of VV-14300 from Cohort 1 will be co-administered with VV-14299 (high dose) via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300\u002FVV-14299 dosing to reduce the risk of immune responses.",[80,85],{"label":91,"type":77,"description":92,"interventionNames":93},"Part 2 - Dose Expansion","The same dose of VV-14300 from Cohort 1 will be co-administered with VV-14299 at the dose selected from Part 1 via ultrasound-guided intramuscular injections on Day 1. Tocilizumab will be administered subcutaneously as an auxiliary medication prior to and after VV-14300\u002FVV-14299 dosing to reduce the risk of immune responses.",[80,85],[95,100],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":67},"GENETIC","VV-14300","VV-14300 will be administered via ultrasound-guided intramuscular injections.",[76,82,87,91],{"type":96,"name":101,"description":102,"armGroupLabels":103,"otherNames":67},"VV-14299","VV-14299 will be co-administered with VV-14300 via ultrasound-guided intramuscular injections.",[82,87,91],[105],{"name":106,"role":107,"phone":108,"phoneExt":67,"email":109},"VP, Medical Affairs","CONTACT","984-884-5058","clinicaltrials@kriyatx.com",[111],{"facility":112,"status":113,"city":114,"state":67,"zip":67,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"Kriya Clinical Trial Site","RECRUITING","Melbourne","Australia","AU",{"type":118,"coordinates":119},"Point",[120,121],144.96332,-37.814,{"lat":121,"lon":120},[124],{"name":106,"role":107,"phone":108,"phoneExt":67,"email":109},{"type":126,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR","100656871","phase-1-vv-14299-and-vv-14300-for-the-treatment-of-type-1-diabetes-100656871",false,"NCT07829302","VV-14299 and VV-14300 for the Treatment of Type 1 Diabetes","A Phase 1\u002F2, First-in-Human, Adaptive, Model-based, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of VV-14299 and VV-14300 (Adeno-associated Virus Vector-mediated Insulin and Glucokinase) in Adults With Long-Standing Type 1 Diabetes and Suboptimal Glycemic Control Using a Continuous Subcutaneous Insulin Infusion (CSII) Pump","PROGRESS","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 (T1D) 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 (C-peptide \\\u003C0.20 ng\u002FmL \\[0.667 nmol\u002FL\\] during a mixed meal tolerance test; 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 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* 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* Documented anti-AAV1 neutralizing antibody titer above the protocol-specified threshold at Screening.\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* 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":139,"type":140},29,"ESTIMATED","INTERVENTIONAL",[143,144],"PHASE1","PHASE2","This study is testing VV-14299 and VV-14300 or VV-14300 alone 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-14299 and VV-14300 are investigational gene therapies that are injected into muscle and are designed to work together to help remove excess sugar from the blood.",[147],"Type 1 Diabetes Mellitus","2026-10-02",{"date":150,"type":151},"2026-10-05","ACTUAL",{"date":153,"type":140},"2026-10",{"date":155,"type":140},"2029-07",{"name":5,"class":6},1]