Идёт набор NCT07231679

A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease

Фаза I / Фаза II С лечением Healthy Volunteers Chronic Kidney Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: IGT-303, Placebo.
Кому может быть актуально: Состояния в реестре: Healthy Volunteers, Chronic Kidney Disease. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австралия, Новая Зеландия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Препарат IGT-303
IGT-303 administered via IV or SC
Препарат Placebo
Saline

Первичные конечные точки

Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) [Срок оценки: From Screening to Day 84.]

Вторичные конечные точки (9)

PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303 [Срок оценки: Day 1 to Day 84.]
PK Parameters of IV and SC IGT-303 [Срок оценки: Day 1 to Day 84]
PK Parameters of IV and SC IGT-303 [Срок оценки: Day 1 to Day 84]
PK Parameters of IV and SC IGT-303 [Срок оценки: Day 1 to Day 84]
PK parameters of IV and SC IGT-303 [Срок оценки: Day 1 to Day 84]
PK parameters of IV and SC IGT-303 [Срок оценки: Day 1 to Day 84]
PK parameters of IV and SC IGT-303 [Срок оценки: Day 1 to Day 84]
PK parameters of IV and SC IGT-303 [Срок оценки: Day 1 to Day 84]
PK parameters of IV and SC IGT-303 [Срок оценки: Day 1 to Day 84]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да