[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ingenia Therapeutics INC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":21,"type":22},94,"ESTIMATED","INTERVENTIONAL",[25,26],"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.",[29,30],"Healthy Volunteers","Chronic Kidney Disease","RECRUITING","2026-10-05",{"date":34,"type":35},"2026-10-07","ACTUAL",{"date":37,"type":35},"2025-10-30",{"date":39,"type":22},"2027-04",{"name":41,"class":42},"Ingenia Therapeutics INC","INDUSTRY",13,""]