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Набор скоро начнётся NCT07281274

ADO-5030 in Bronchoconstriction Challenge, Phase 1b

Фаза I С лечением Asthma (Diagnosis)

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: ADO-5030.
Кому может быть актуально
Состояния в реестре: Asthma (Diagnosis). 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
США
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 Single-Center, Single-Arm, Phase 1b Study to Evaluate the Effects of ADO-5030 on a Bronchoconstriction Challenge

Обзор

This is a Phase 1 study to learn about the safety and pharmacokinetics of the study drug in patients with asthma and whether the study drug has effect during a respiratory challenge.

Вмешательства

  • Препарат ADO-5030
    Single oral dose of ADO-5030.

Первичные конечные точки

  • Change from baseline in PC20 AMP. [Срок оценки: As this is a single dose trial, the timeframe is the duration in which PC20 AMP is reached during the AMP Challenge with ADO-5030 on Day 1.]
Вторичные конечные точки (6)
  • Frequency of ADO-5030 Treatment-Emergent Adverse Events (TEAEs). [Срок оценки: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.]
  • Severity of ADO-5030 Treatment-Emergent Adverse Events (TEAEs). [Срок оценки: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.]
  • Frequency of ADO-5030 Treatment-Related Adverse Events (TRAEs). [Срок оценки: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.]
  • Severity of ADO-5030 Treatment-Related Adverse Events (TRAEs). [Срок оценки: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.]
  • Frequency of Adverse Events (AEs). [Срок оценки: Enrollment to End of Study, assessed up to 9 days post-dose.]
  • Severity of Adverse Events (AEs). [Срок оценки: Enrollment to End of Study, assessed up to 9 days post-dose.]

Критерии участия

Критерии включения

  • Males and females ages 18-65 years, inclusive
  • History of well-controlled mild or moderate persistent asthma for at least 6 months prior to screening.
  • Well controlled asthma demonstrated by asthma control test (ACT) score ≥20 at Visit 1.
  • Reactivity to AMP, as determined in Protocol 19512 (Screening Protocol of Asthmatic, Allergic Rhinitic, or Control Participants for Experimental Challenges). Reactivity is defined as having a PC20 AMP at or before 80mg/mL.
  • Two replicable (within 2 dose doublings) AMP challenges. The two AMP challenges must occur within 28 days of each other.
  • Pre-bronchodilator FEV1 ≥ 60% of predicted at screening.
  • Normal or not clinically significant (NCS) safety laboratory results from Visit 1 prior to Visit 2.
  • Negative pregnancy test for females who have not had a hysterectomy with oophorectomy or who have not been amenorrheic for 12 months or more.
  • Willing to abstain from caffeine for 24 hours prior to each AMP challenge.
  • Willing and able to give informed consent.

Критерии исключения

  • Any chronic medical condition considered by the PI as a contraindication to participation in the study including significant cardiovascular disease, uncontrolled diabetes, chronic renal disease, uncontrolled chronic thyroid disease, history of chronic infections or immunodeficiency.
  • Inability to refrain from using inhaled corticosteroids (ICS), cromolyn, long-acting-beta-agonists (LABA), and leukotriene modifiers (LT) for 48 hours.
  • Pregnancy or nursing a baby.
  • A positive history for HIV, TB, HBV, or HCV.
  • Any asthma exacerbation requiring oral corticosteroids within 12 months of screening or that resulted in overnight hospitalization or an urgent care visit requiring additional treatment for asthma.
  • Uncontrolled asthma at enrollment Visit 1 defined as ACT score <20.
  • Current smokers or a smoking history of ≥ 10 pack years. A subject may not have used any inhaled tobacco products in the 12-month period preceding Visit 1.
  • Known allergy/sensitivity to theophylline.
  • Any acute infection requiring antibiotics within 4 weeks or fever of unknown origin within 4 weeks of screening. Subjects having an intercurrent respiratory infection during the study will be permitted to reenroll.
  • Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
  • Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Virginia — Charlottesville

Идентификаторы

NCT: NCT07281274 · ADO-5030-102

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗