Идёт набор NCT06324604

Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients

Фаза I С лечением Healthy Volunteers Type 1 Diabetes

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: Placebo, MTX-101.
Кому может быть актуально: Состояния в реестре: Healthy Volunteers, Type 1 Diabetes. Базовые параметры: 18 лет — 65 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
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells.

Подробное описание

A Phase 1, Part A -prospective, randomized, single-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in healthy adults (HA). Part B - A multi-center, randomized, open-label study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in participants with type 1 diabetes (T1D).

Вмешательства

Препарат Placebo
MTX-101
Препарат MTX-101
MTX-101 (bispecific CD8 Treg modulator)

Первичные конечные точки

Safety of single, ascending dose levels of MTX-101 [Срок оценки: Enrollment to 8 weeks post dose]
Safety of multiple, ascending dose levels of MTX-101 [Срок оценки: Enrollment to 11 weeks following the last dose]

Вторичные конечные точки (4)

pharmacokinetics (PK) of MTX-101 [Срок оценки: Enrollment to 11 weeks following the last dose]
pharmacokinetics (PK) of MTX-101 [Срок оценки: Enrollment to 11 weeks following the last dose]
pharmacokinetics (PK) of MTX-101 [Срок оценки: Enrollment to 11 weeks following the last dose]
anti-drug antibody (ADA) formation [Срок оценки: Enrollment to 11 weeks following the last dose]

Критерии участия

Критерии включения

Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing (Day 1).
Healthy individuals without known current or chronic medical conditions, including no history of any autoimmune diseases, in the opinion of the Investigator.
Body mass index (BMI) ≥ 18 kg/m2 and ≤ 35 kg/m2 AND body weight ≥ 55 and ≤ 120 kg.
Negative Coronavirus Disease 2019 (COVID-19) test within 24 hours prior to each dose.
Persons of child-bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective method(s) of birth control from Day 1 through the duration of the study.

Критерии исключения

Clinically significant findings in physical examination (PE), vital signs (blood pressure, heart rate, and body temperature), electrocardiogram (ECG), and safety laboratory parameters at Screening in the opinion of the Investigator.
Prior or concurrent malignancies.
Renal function calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation with estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m2 or abnormal level of proteinuria detected by dipstick at the time of Screening.
Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
Receipt of an investigational drug within 28 days or 5 half-lives (whichever is longer) of the investigational drug(s) prior to Day 1.
Positive serology for human immunodeficiency virus (HIV) type 1 or 2, hepatitis (Hep) B surface antigen, or Hep C.
Positive test results for drug screen, including alcohol, at the time of Screening or on Day 1 prior to randomization.
Use of tobacco or nicotine-containing products more than the equivalent of 5 cigarettes/week within 30 days prior to (first) dosing.

Participants must abstain from nicotine use while inpatient.