Recruiting NCT07231679
A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IGT-303, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers, Chronic Kidney Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Placebo-Controlled, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, and Pharmacokinetics of IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
Overview
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
- Drug IGT-303
IGT-303 administered via IV or SC - Drug Placebo
Saline
Primary outcome measures
- Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) [Time frame: From Screening to Day 84.]
Secondary outcome measures (9)
- PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303 [Time frame: Day 1 to Day 84.]
- PK Parameters of IV and SC IGT-303 [Time frame: Day 1 to Day 84]
- PK Parameters of IV and SC IGT-303 [Time frame: Day 1 to Day 84]
- PK Parameters of IV and SC IGT-303 [Time frame: Day 1 to Day 84]
- PK parameters of IV and SC IGT-303 [Time frame: Day 1 to Day 84]
- PK parameters of IV and SC IGT-303 [Time frame: Day 1 to Day 84]
- PK parameters of IV and SC IGT-303 [Time frame: Day 1 to Day 84]
- PK parameters of IV and SC IGT-303 [Time frame: Day 1 to Day 84]
- PK parameters of IV and SC IGT-303 [Time frame: Day 1 to Day 84]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- Nucleus Network — Herston
- University of Sunshine Coast-Morayfield — Morayfield
- University of the Sunshine Coast Clinical Trials-Southbank — Morayfield
New Zealand · 2 centers
- Pacific Clinical Research Network — Takapuna
- Momentum Clinical Research — Waikanae Beach
Identifiers
NCT: NCT07231679 · IGT-303-01-CKD01