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New treatment option for Healthy Volunteers
Official title A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT07231679
What this study is testing
What is IGT-303?
IGT-303 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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...
- Use of cigarettes exceeding \>5 cigarettes per week at time of Screening; social/casual cigarette use (≤5 per week) is permitted during the study...
- 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...
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Herston, Brisbane, Australia
- Morayfield, Queensland, Australia
- Takapuna, Auckland, New Zealand
- Waikanae Beach, Kapiti Coast, New Zealand
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herston, Brisbane, Australia; Morayfield, Queensland, Australia; Takapuna, Auckland, New Zealand; Waikanae Beach, Kapiti Coast, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.