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Идёт набор NCT07665892

Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma

Фаза I С лечением Safety in Asthma Patients

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: ASY202, Placebo.
Кому может быть актуально
Состояния в реестре: Safety in Asthma Patients. 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
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 Phase 1 Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single-dose of ASY202 in Adults With Asthma

Обзор

This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2 period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma. Following screening, eligible participants will be enrolled and randomized to one of two treatment sequences. Participants will receive a single inhaled dose of ASY202 and a single inhaled dose of placebo, each administered once during separate study periods. During each treatment period, subjects will stay in the clinical research unit for safety monitoring and PK assessments, including serial blood sampling, spirometry, vital signs, clinical laboratory tests, and ECGs. Each period will include post dose assessments for up to 24 hours. Participants will return for their next treatment period after a washout interval to ensure complete clearance of study medication. All subjects will receive both treatments over the course of the study. A follow-up visit will occur after the last dose to assess ongoing safety and tolerability.

Вмешательства

  • Комбинированный продукт ASY202
    ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI).
  • Комбинированный продукт Placebo
    Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.

Первичные конечные точки

  • Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma. [Срок оценки: Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.]
Вторичные конечные точки (12)
  • Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma. [Срок оценки: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.]
  • Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma. [Срок оценки: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.]
  • Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma. [Срок оценки: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.]
  • Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma. [Срок оценки: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours]
  • Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma. [Срок оценки: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours]
  • Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma [Срок оценки: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours]
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of a single dose of ASY202 2 mg compared with placebo in adults with asthma. [Срок оценки: Up to 24 hours post dose and safety follow up to seven days after last dose]
  • Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma. [Срок оценки: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration]
  • Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma. [Срок оценки: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration]
  • Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma. [Срок оценки: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration]
  • Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma [Срок оценки: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration]
  • Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma [Срок оценки: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration]

Критерии участия

Критерии включения

  • Adults aged 18-55 years
  • Diagnosed asthma
  • Stable asthma treatment
  • Non smoker
  • BMI 18.5-35 kg/m²
  • Women of childbearing potential and men agree to use acceptable contraception

Критерии исключения

  • Asthma exacerbation requiring systemic steroids, ER visit, or hospitalization within 3 months
  • Respiratory tract infection within 4 weeks prior to screening
  • Use of oral or IV corticosteroids
  • Use of prohibited medications (e.g., CYP3A4 modulators, triptans, vasoconstrictors, QT prolongers, theophylline, systemic steroids)
  • Other lung diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD)) or conditions interfering with spirometry
  • Unstable asthma or unresolved safety concerns before dosing
  • Clinically significant cardiovascular disease or ECG abnormalities contraindicating DHE
  • Three or more risk factors for Coronary Artery Disease (CAD) (hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age)
  • Pregnancy, breastfeeding, or unwillingness to use required contraception

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 3 центра
  • Sun City Clinical Research — Glendale
  • CenExel- Anaheim Clinical trials LLC — Anaheim
  • Worldwide Clinical Trials- Early Phase Research Unit — San Antonio

Идентификаторы

NCT: NCT07665892 · VFC202-103

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗