A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
Recruiting
Phase 1Phase 2Interventional Study
Healthy VolunteersChronic Kidney Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
94 (estimated)
Sponsor
Ingenia Therapeutics INC · Industry
Who this trial is looking for
This trial is looking for healthy volunteers and people with chronic kidney disease. Participants will receive either the study drug IGT-303 or a placebo to help researchers check its safety.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I can understand the study and provide written consent.
My BMI is between 18.5 and 40.
I have chronic kidney disease stage 2-3b from Type 2 diabetic nephropathy.
My UACR is between 30 and 5000 mg/g.
I have been on stable antihypertensive or antidiabetic medication for at least 90 days.
I am willing to follow study requirements including overnight stays.
You may not be able to join if
I have a known allergy to the study medication or its ingredients.
I smoke more than 5 cigarettes a week.
I tested positive for drugs or alcohol at the screening.
I have any illness that may affect my safety in the study.
I have diabetic macular edema or vitreous hemorrhage (if in Cohort 9).
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 fo…
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.
Trial Locations
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Status
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…
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.
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