RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease

Sponsor: Ingenia Therapeutics INC • ClinicalTrials.gov ID: NCT07231679

Registry updated: 2026-10-07

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Description

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: Is IGT-303 safe as a single dose or multiple dose regimen when applied under the skin (subcutaneously (SC)) or to a vein (intravenously (IV)). Researchers will compare IGT-303 against a placebo to see if IGT-303 is safe for use. Participants will be assigned to either IGT-303 or placebo and assessed for safety and tolerability for the duration of the study.

Interventions

IGT-303 (Drug)
IGT-303 administered via IV or SC
Placebo (Drug)
Saline

Eligibility criteria

Inclusion Criteria: * Participant 18-75 years of age, inclusive, at Screening; * 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; * Body mass index (BMI) within the range of 18.5 to 40 kg/m2 at Screening; * Have a diagnosis of chronic kidney disease stage 2-3b, resulting from Type 2 diabetic nephropathy; * UACR \>30 mg/g, \<5000 mg/g at Screening; * If taking antihypertensive and/or antidiabetic medication, doses of medications must be stable for at least 90 days prior to Screening; * Stable eGFR. in the opinion of the Investigator, for at least 90 days prior to Screening; * HbA1C \<9.0% at Screening; * 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 * In the opinion of the Investigator, is able to adhere to the requirements of the study, including required overnight stays in the research site; * For participants in Cohort 9 only, have a diagnosis of nonproliferative diabetic retinopathy Exclusion Criteria: * 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/drug allergies; * Use of cigarettes exceeding \>5 cigarettes per week at time of Screening; social/casual cigarette use (≤5 per week) is permitted during the study, but participants must be willing to abstain during inpatient confinement; * Positive urine screen for drugs of abuse including tetrahydrocannabinol or has a positive breathalyzer test, at Screening or at Day -1; * Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data * For participants in Cohort 9 only, presence of diabetic macular edema with anti-vascular endothelial growth factor (VEGF) treatment or vitreous hemorrhage.

Conditions

Healthy Volunteers Chronic Kidney Disease

Locations

Balboa Nephrology - Chula Vista — Chula Vista, California, United States
Clinical Research of Central Florida — Lakeland, Florida, United States
Piedmont HealthCare — Statesville, North Carolina, United States
Wilmington Health — Wilmington, North Carolina, United States
Nucleus Network — Herston, Brisbane, Australia
Renal Research — Gosford, New South Wales, Australia
Concord Repatriation General Hospital — Sydney, New South Wales, Australia
University of the Sunshine Coast Clinical Trials-Southbank — Morayfield, Queensland, Australia
University of the Sunshine Coast-Morayfield — Morayfield, Queensland, Australia
Sunshine Hospital — Saint Albans, Victoria, Australia
Pacific Clinical Research Network — Takapuna, Auckland, New Zealand
Momentum Clinical Research — Waikanae Beach, Kapiti Coast, New Zealand
Seoul National University Hospital — Seoul, South Korea

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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