NCT07231679 A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
| NCT ID | NCT07231679 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ingenia Therapeutics INC |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2025-10-30 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 94 participants in total. It began in 2025-10-30 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 and Day -1; * If taking antihypertensive and/or antidiabetic medication, doses of medications must be stable for at least 90 days prior to 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.
Contact & Investigator
Emma Trowbridge, MD
PRINCIPAL INVESTIGATOR
Nucleus Network
Frequently Asked Questions
Who can join the NCT07231679 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07231679 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07231679 currently recruiting?
Yes, NCT07231679 is actively recruiting participants. Contact the research team at jc@curryclinicalconsulting.com for enrollment information.
Where is the NCT07231679 trial being conducted?
This trial is being conducted at Herston, Australia, Morayfield, Australia, Morayfield, Australia, Takapuna, New Zealand and 1 additional location.
Who is sponsoring the NCT07231679 clinical trial?
NCT07231679 is sponsored by Ingenia Therapeutics INC. The principal investigator is Emma Trowbridge, MD at Nucleus Network. The trial plans to enroll 94 participants.