Recruiting
Phase 1/2
A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
Condition(s) studied
Healthy VolunteersChronic Kidney Disease
Investigational drug(s) / intervention(s)
IGT-303Placebo
IGT-303: IGT-303 administered via IV or SC
Placebo: Saline
Study 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
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.
Primary outcome measure(s)
- Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) — From Screening to Day 84.
The number and severity (by Grade) will be measured.
Trial sites (13)
| Facility | City | Region | Status |
| Balboa Nephrology - Chula Vista |
Chula Vista |
California |
Not Yet Recruiting |
| Clinical Research of Central Florida |
Lakeland |
Florida |
Not Yet Recruiting |
| Piedmont HealthCare |
Statesville |
North Carolina |
Not Yet Recruiting |
| Wilmington Health |
Wilmington |
North Carolina |
Not Yet Recruiting |
| Nucleus Network |
Herston |
Brisbane |
Recruiting |
| Renal Research |
Gosford |
New South Wales |
Recruiting |
| Concord Repatriation General Hospital |
Sydney |
New South Wales |
Recruiting |
| University of the Sunshine Coast Clinical Trials-Southbank |
Morayfield |
Queensland |
Recruiting |
| University of the Sunshine Coast-Morayfield |
Morayfield |
Queensland |
Recruiting |
| Sunshine Hospital |
Saint Albans |
Victoria |
Recruiting |
| Pacific Clinical Research Network |
Takapuna |
Auckland |
Recruiting |
| Momentum Clinical Research |
Waikanae Beach |
Kapiti Coast |
Recruiting |
| Seoul National University Hospital |
Seoul |
South Korea |
Recruiting |
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