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Набор скоро начнётся NCT07746817

A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis

Фаза I С лечением Atopic Dermatitis Healthy Participants

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: BYN-001, Placebo.
Кому может быть актуально
Состояния в реестре: Atopic Dermatitis, Healthy Participants. Базовые параметры: 18 лет — 55 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
Список центров уточняется — проверьте первичный протокол.
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 Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BYN-001 in Healthy Adult Participants and Participants With Moderate to Severe Atopic Dermatitis

Обзор

This first-in-human study evaluates BYN-001, a humanized IgG1 monoclonal antibody targeting interleukin-25 (IL-25), a cytokine implicated in atopic dermatitis. Parts A and B are randomized, double-blind, placebo-controlled single and multiple ascending dose cohorts in healthy adults, that will assess safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of BYN-001. Part C will assess BYN-001 in adults with moderate to severe atopic dermatitis.

Подробное описание

Atopic dermatitis (AD) is a common chronic inflammatory skin disease for which current type 2 cytokine-targeted biologics leave a substantial proportion of patients with an inadequate response or residual pruritus. IL-25 acts upstream of type 2 inflammation and has been shown to drive pruritus and epidermal barrier dysfunction. BYN-001 selectively binds and neutralises IL-25 (with a long predicted terminal half-life), supporting an infrequent dosing interval.

Part A will consist of a single ascending dose (SAD) design, with administration in up to five cohorts. Part B will consist of a multiple ascending dose (MAD) design, with administration in up to three cohorts. Both parts will enroll healthy participants and will be conducted under a sentinel dosing approach, with dose escalation decisions governed by a Safety Monitoring Committee (SMC) at each escalation step.

Part C will enroll participants with moderate to severe AD.

Вмешательства

  • Биопрепарат BYN-001
    BYN-001 will be administered by subcutaneous injection. In Part A, a Single Ascending Dose (SAD) design will be implemented across up to five cohorts, with healthy participants receiving a single dose of BYN-001. In Part B, a Multiple Ascending Dose (MAD) design will be implemented with healthy participants receiving multiple doses of BYN-001.
  • Препарат Placebo
    Part A SAD healthy participants will receive a single subcutaneous injection of placebo. Part B MAD healthy participants will receive multiple doses of subcutaneous injection of placebo.

Первичные конечные точки

  • Incidence and severity of adverse events (AEs) [Срок оценки: From first dose through end of study (up to Week 48 for BYN-001 recipients; up to 2 weeks post-unblinding for placebo recipients)]
Вторичные конечные точки (4)
  • Pharmacokinetic parameters of BYN-001 [Срок оценки: Serial PK sampling per the Schedule of Assessments, through Week 48]
  • Incidence of anti-drug antibodies (ADA) to BYN-001 [Срок оценки: Baseline through Week 48]
  • Pharmacokinetic parameters of BYN-001 [Срок оценки: Serial PK sampling per the Schedule of Assessments, through Week 48]
  • Titer of anti-drug antibodies (ADA) to BYN-001 [Срок оценки: Baseline through Week 48]

Критерии участия

Part A and B Key Inclusion Criteria:

  • Age 18-55 years of age
  • Must be in good health with no significant medical conditions
  • Willing and able to attend all study visits and comply with study requirements
  • Able and willing to provide written informed consent

Part A and B Exclusion Criteria:

  • Evidence of clinically significant condition or disease
  • Any physical or psychosocial condition that prohibits study completion
  • Know history of illicit drug use or abuse, alcoholism and/or smoking more than -5 cigarettes a day in the prior 3 months
  • History of sever allergic reactions of hypersensitivity

Part C Inclusion Criteria

  • Age 18-55 years of age
  • Must be in good health with no significant medical conditions
  • Willing and able to attend all study visits and comply with study requirements
  • Able and willing to provide written informed consent
  • Documented chromic atopic dermatitis within 1 year prior to screening
  • Moderate to severe atopic dermatitis

Part C Key Exclusion Criteria

  • Evidence of clinically significant condition or disease
  • Any physical or psychosocial condition that prohibits study completion
  • Know history of illicit drug use or abuse, alcoholism and/or smoking more than 5 cigarettes a day in the prior 3 months
  • History of sever allergic reactions of hypersensitivity
  • Incomplete washout of prior atopic dermatitis medications
  • Other confounding skin diseases

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07746817 · BYN-001-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗