[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610753":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":47,"interventions":60,"overallOfficials":68,"centralContacts":73,"locations":83,"responsibleParty":215,"collaborators":37,"id":217,"slug":218,"hasResults":219,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":37,"eligibilityCriteria":223,"healthyVolunteers":224,"sex":225,"minAge":226,"maxAge":227,"enrollmentInfo":228,"targetDuration":37,"studyType":231,"phases":232,"briefSummary":235,"conditions":236,"keywords":37,"overallStatus":128,"whyStopped":37,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":248},{"fullName":5,"class":6},"Ingenia Therapeutics INC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)","The number and severity (by Grade) will be measured.","From Screening to Day 84.",[14,18,22,24,26,29,31,33,35],{"measure":15,"description":16,"timeFrame":17},"PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303","Maximum observed concentration (Cmax)","Day 1 to Day 84.",{"measure":19,"description":20,"timeFrame":21},"PK Parameters of IV and SC IGT-303","Observed time of maximum concentration (Tmax)","Day 1 to Day 84",{"measure":19,"description":23,"timeFrame":21},"Terminal exponential rate constant, determined using the linear least squares regression of the terminal phase of the log-serum concentration time profile (λz)",{"measure":19,"description":25,"timeFrame":21},"Terminal exponential half-life, calculated as ln(2)\u002Fλz (T1\u002F2)",{"measure":27,"description":28,"timeFrame":21},"PK parameters of IV and SC IGT-303","Area under the concentration-time curve calculated using linear trapezoidal rule from time zero to time t, where t is the time of the last observed quantifiable concentration (AUC0-t)",{"measure":27,"description":30,"timeFrame":21},"Area under the concentration-time curve from time zero to infinity, defined as AUC0-t + Ct\u002Fλz (AUC0-∞)",{"measure":27,"description":32,"timeFrame":21},"Total clearance (CL), defined as dose\u002FAUC0-∞",{"measure":27,"description":34,"timeFrame":21},"Terminal volume of distribution (Vz), defined as CL\u002Fλz",{"measure":27,"description":36,"timeFrame":21},"Absolute bioavailability (F), defined as the dose-corrected (AUC0-∞ SC) \u002F (AUC0-∞ IV)",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":44},"DOUBLE",[45,46],"PARTICIPANT","INVESTIGATOR",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"IGT-303","EXPERIMENTAL","Part A: single ascending dose (SAD), 6 cohorts Part B: multiple ascending dose (MAD), 3 cohorts",[53],"Drug: IGT-303",{"label":55,"type":56,"description":57,"interventionNames":58},"Placebo","PLACEBO_COMPARATOR","Placebo (normal saline)",[59],"Drug: Placebo",[61,65],{"type":62,"name":49,"description":63,"armGroupLabels":64,"otherNames":37},"DRUG","IGT-303 administered via IV or SC",[49],{"type":62,"name":55,"description":66,"armGroupLabels":67,"otherNames":37},"Saline",[55],[69],{"name":70,"affiliation":71,"role":72},"Emma Trowbridge, MD","Nucleus Network","PRINCIPAL_INVESTIGATOR",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":37,"email":78},"Jennifer Curry, PharmD","CONTACT","317-726-9118","jc@curryclinicalconsulting.com",{"name":80,"role":76,"phone":81,"phoneExt":37,"email":82},"Jinsam You, PhD","617-440-2518","jyou@ingeniatx.com",[84,98,108,118,127,139,149,158,168,173,183,195,205],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":37},"Balboa Nephrology - Chula Vista","NOT_YET_RECRUITING","Chula Vista","California","91910","United States","US",{"type":93,"coordinates":94},"Point",[95,96],-117.0842,32.64005,{"lat":96,"lon":95},{"facility":99,"status":86,"city":100,"state":101,"zip":102,"country":90,"countryCode":91,"cosmosGeoPoint":103,"geoPoint":107,"contacts":37},"Clinical Research of Central Florida","Lakeland","Florida","33805",{"type":93,"coordinates":104},[105,106],-81.9498,28.03947,{"lat":106,"lon":105},{"facility":109,"status":86,"city":110,"state":111,"zip":112,"country":90,"countryCode":91,"cosmosGeoPoint":113,"geoPoint":117,"contacts":37},"Piedmont HealthCare","Statesville","North Carolina","28625",{"type":93,"coordinates":114},[115,116],-80.8873,35.78264,{"lat":116,"lon":115},{"facility":119,"status":86,"city":120,"state":111,"zip":121,"country":90,"countryCode":91,"cosmosGeoPoint":122,"geoPoint":126,"contacts":37},"Wilmington Health","Wilmington","28412",{"type":93,"coordinates":123},[124,125],-77.94604,34.23556,{"lat":125,"lon":124},{"facility":71,"status":128,"city":129,"state":130,"zip":131,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":37},"RECRUITING","Herston","Brisbane","4006","Australia","AU",{"type":93,"coordinates":135},[136,137],153.01852,-27.44453,{"lat":137,"lon":136},{"facility":140,"status":128,"city":141,"state":142,"zip":143,"country":132,"countryCode":133,"cosmosGeoPoint":144,"geoPoint":148,"contacts":37},"Renal Research","Gosford","New South Wales","2250",{"type":93,"coordinates":145},[146,147],151.34399,-33.4244,{"lat":147,"lon":146},{"facility":150,"status":128,"city":151,"state":142,"zip":152,"country":132,"countryCode":133,"cosmosGeoPoint":153,"geoPoint":157,"contacts":37},"Concord Repatriation General Hospital","Sydney","2139",{"type":93,"coordinates":154},[155,156],151.20732,-33.86785,{"lat":156,"lon":155},{"facility":159,"status":128,"city":160,"state":161,"zip":162,"country":132,"countryCode":133,"cosmosGeoPoint":163,"geoPoint":167,"contacts":37},"University of the Sunshine Coast Clinical Trials-Southbank","Morayfield","Queensland","4506",{"type":93,"coordinates":164},[165,166],152.94907,-27.10876,{"lat":166,"lon":165},{"facility":169,"status":128,"city":160,"state":161,"zip":162,"country":132,"countryCode":133,"cosmosGeoPoint":170,"geoPoint":172,"contacts":37},"University of the Sunshine Coast-Morayfield",{"type":93,"coordinates":171},[165,166],{"lat":166,"lon":165},{"facility":174,"status":128,"city":175,"state":176,"zip":177,"country":132,"countryCode":133,"cosmosGeoPoint":178,"geoPoint":182,"contacts":37},"Sunshine Hospital","Saint Albans","Victoria","3021",{"type":93,"coordinates":179},[180,181],144.8,-37.73333,{"lat":181,"lon":180},{"facility":184,"status":128,"city":185,"state":186,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":37},"Pacific Clinical Research Network","Takapuna","Auckland","0622","New Zealand","NZ",{"type":93,"coordinates":191},[192,193],174.77583,-36.79167,{"lat":193,"lon":192},{"facility":196,"status":128,"city":197,"state":198,"zip":199,"country":188,"countryCode":189,"cosmosGeoPoint":200,"geoPoint":204,"contacts":37},"Momentum Clinical Research","Waikanae Beach","Kapiti Coast","5036",{"type":93,"coordinates":201},[202,203],175.021,-40.86384,{"lat":203,"lon":202},{"facility":206,"status":128,"city":207,"state":37,"zip":208,"country":209,"countryCode":37,"cosmosGeoPoint":210,"geoPoint":214,"contacts":37},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":93,"coordinates":211},[212,213],126.9784,37.566,{"lat":213,"lon":212},{"type":216,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100610753","phase-1-a-study-to-investigate-igt-303-in-healthy-volunteers-and-participants-with-chronic-kidney-disease-100610753",false,"NCT07231679","A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease","A Randomized, Placebo-Controlled, Multicenter, Phase 1\u002F2a Study to Investigate the Safety, Tolerability, and Pharmacokinetics of IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease","Inclusion Criteria:\n\n* Participant 18-75 years of age, inclusive, at Screening;\n* Able to understand the key components of the study as described in the written informed consent document, and willing and able to provide written informed consent;\n* Body mass index (BMI) within the range of 18.5 to 40 kg\u002Fm2 at Screening;\n* Have a diagnosis of chronic kidney disease stage 2-3b, resulting from Type 2 diabetic nephropathy;\n* UACR \\>30 mg\u002Fg, \\\u003C5000 mg\u002Fg at Screening;\n* If taking antihypertensive and\u002For antidiabetic medication, doses of medications must be stable for at least 90 days prior to Screening;\n* Stable eGFR. in the opinion of the Investigator, for at least 90 days prior to Screening;\n* HbA1C \\\u003C9.0% at Screening;\n* Participants assigned male at birth (AMAB) will be either sterile or agree to use an approved method of contraception from Screening until at least 5 half-lives plus 90 days after the last dose of study drug, or do not engage in sexual relations which carry a risk of pregnancy (does include abstinence), and agree to refrain from sperm donation and in vitro fertilization until 5 half-lives plus 90 days after the last dose of the study drug; Participants assigned female at birth (AFAB) must be of non-childbearing potential or agree to use two highly effective methods of conception from Screening until at least 5 half-lives plus 30 days after the last dose of study drug or do not engage in sexual relations which carry a risk of pregnancy (does include abstinence), and agree to refrain from egg donation and in vitro fertilization until 5 half-lives plus 30 days after the last dose of the study drug\n* In the opinion of the Investigator, is able to adhere to the requirements of the study, including required overnight stays in the research site;\n* For participants in Cohort 9 only, have a diagnosis of nonproliferative diabetic retinopathy\n\nExclusion Criteria:\n\n* Known allergy to study medication or its components (non-medicinal ingredients) or a history of a severe allergic reaction to any drug or history of multiple food\u002Fdrug allergies;\n* Use of cigarettes exceeding \\>5 cigarettes per week at time of Screening; social\u002Fcasual cigarette use (≤5 per week) is permitted during the study, but participants must be willing to abstain during inpatient confinement;\n* Positive urine screen for drugs of abuse including tetrahydrocannabinol or has a positive breathalyzer test, at Screening or at Day -1;\n* Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data\n* For participants in Cohort 9 only, presence of diabetic macular edema with anti-vascular endothelial growth factor (VEGF) treatment or vitreous hemorrhage.",true,"ALL","18 Years","75 Years",{"count":229,"type":230},94,"ESTIMATED","INTERVENTIONAL",[233,234],"PHASE1","PHASE2","The goal of this clinical trial is to observe the safety of IGT-303 in healthy volunteers and participants with Chronic Kidney Disease. The main question it aims to answer is:\n\nIs IGT-303 safe as a single dose or multiple dose regimen when applied under the skin (subcutaneously (SC)) or to a vein (intravenously (IV)).\n\nResearchers will compare IGT-303 against a placebo to see if IGT-303 is safe for use.\n\nParticipants will be assigned to either IGT-303 or placebo and assessed for safety and tolerability for the duration of the study.",[237,238],"Healthy Volunteers","Chronic Kidney Disease","2026-10-05",{"date":241,"type":242},"2026-10-07","ACTUAL",{"date":244,"type":242},"2025-10-30",{"date":246,"type":230},"2027-04",{"name":5,"class":6},13]