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Идёт набор NCT07709494

A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa

Фаза I С лечением Healthy Participants Non-cystic Fibrosis Bronchiectasis

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: Rev-56 for Inhalation, Placebo: Normal saline.
Кому может быть актуально
Состояния в реестре: Healthy Participants, Non-cystic Fibrosis Bronchiectasis. Базовые параметры: 18 лет — 80 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 Sequential, Phase 1a/1b, Double-blind, 2-part Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Rev-56 for Inhalation Compared With Placebo in Healthy Adult Participants and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic Pseudomonas Aeruginosa

Обзор

This is a Phase 1a/1b study to test the safety, tolerability, microbiological response, and pharmacokinetics of inhaled Rev-56 compared to placebo in adult healthy participants and non-cystic fibrosis bronchiectasis (NCFB) patients with P. aeruginosa, respectively. Phase 1a (Part A) will evaluate single doses of inhaled Rev-56 in adult healthy participants and includes up to 5 cohorts. Eligible participants will be randomized to active treatment or placebo in a 3:1 randomization scheme. Phase 1b (Part B) will evaluate the safety, tolerability, microbiological response, and pharmacokinetics of multiple doses of inhaled Rev-56 in NCFB patients with P. aeruginosa and includes 2 cohorts evaluating once daily dosing and twice daily dosing, respectively. Eligible participants will be randomized to active treatment or placebo in a 2:1 randomization scheme.

Вмешательства

  • Комбинированный продукт Rev-56 for Inhalation
    administered by inhalation via an investigational nebulizer device
  • Препарат Placebo: Normal saline
    administered by inhalation via an investigational nebulizer device

Первичные конечные точки

  • Incidence and severity of treatment-emergent adverse events (AEs) [Срок оценки: 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)]
  • Number of participants with clinically significant abnormalities in lab parameters, vital signs, respiratory function, and ECG parameters graded by FDA Toxicity Grading Scale (for healthy participants) and DAIDS Toxicity Tables (for NCFB patients) [Срок оценки: 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)]
Вторичные конечные точки (10)
  • Maximum observed concentration (Cmax) of Rev-56 [Срок оценки: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation]
  • Time to Cmax of Rev-56 (Tmax) [Срок оценки: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation]
  • Area under the curve from time 0 to last measurable concentration (AUC0-last) [Срок оценки: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation]
  • Area under the curve from time 0 to 24 hours after completion of dosing (AUC0-24) [Срок оценки: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation]
  • Area under the curve from time 0 to infinity (AUC0-inf) [Срок оценки: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation]
  • Clearance of Rev-56 (CL/F) [Срок оценки: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation]
  • Half-life of Rev-56 (t½) [Срок оценки: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation]
  • Volume of distribution of Rev-56 (Vz/F) [Срок оценки: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation]
  • Minimum observed concentration of Rev-56 (Cmin) [Срок оценки: NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation]
  • Mean P. aeruginosa burden (CFU/mL) in sputum culture compared to baseline [Срок оценки: 28 days (NCFB patients with P. aeruginosa)]

Критерии участия

Inclusion Criteria (Healthy Participants):

  • Healthy male and female participants aged 18 to 55 years, inclusive
  • Body mass index > 18 to ≤ 32 kg/m\^2
  • Forced expiratory volume in 1 second (FEV1) ≥ 80%
  • Creatinine clearance ≥ 90 mL/min
  • Normal laboratory values and physical exam at screening, or Grade 1 abnormalities that are not clinically significant

Inclusion Criteria (NCFB Patients with P. aeruginosa):

  • Male and female NCFB patients aged 18 to 80 years, inclusive
  • Bronchiectasis confirmed by prior computerized tomography (CT) scan
  • Chronic P. aeruginosa infection (≥ 2 positive cultures within prior 12 months)
  • Screening sputum culture positive for P. aeruginosa at ≥ 10\^4 CFU/mL
  • FEV1 ≥ 50% (post bronchodilator)

Exclusion Criteria (Healthy Participants):

  • Clinically significant medical history
  • Acute illness within 4 weeks of screening
  • Current smoker or nicotine user
  • History of alcohol abuse (within prior 12 months) or drug/chemical abuse

Exclusion Criteria (NCFB Patients with P. aeruginosa):

  • Primary asthma, chronic obstructive pulmonary disease (COPD), or cystic fibrosis (CF)
  • More than 2 pulmonary exacerbations requiring IV antibiotics within 12 months prior to screening
  • Receipt of antibiotics (excluding macrolides) within 30 days prior to screening
  • Clinically significant hemoptysis requiring intervention within 30 days prior to screening
  • Receiving anti-infective treatment for concurrent nontuberculosis mycobacteria (NTM) or fungal infection

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Syneos Health Miami — Miami

Идентификаторы

NCT: NCT07709494 · Rev-56-001 · 75N93022C00061

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗