RIG 101 Trial in Healthy Adults and Adults With Asthma

Официальное название

A Two-part Randomized, Double-blind Placebo Controlled Trial to Assess the Safety and Tolerability of Single and Repeat Ascending Intranasal Doses of RIG-101 in Healthy Participants Followed by Repeat Daily Administration in Adult Participants With Asthma [Part A] Followed by a Randomized Double-blind Placebo Controlled Part to Assess the Efficacy and Safety of RIG-101 in Adult Participants With Asthma Before and After Viral Challenge With Human Rhinovirus RV-A16 [Part B].

Обзор

Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy

Вмешательства

• Препарат RIG-101
  Single, and repeat escalating intranasal administrations of RIG-101
• Другое Placebo
  Single and repeat Intranasal administrations

Первичные конечные точки

• Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Day 1-35]
• Systolic/Diastolic blood pressure [Срок оценки: Day 0 - 35]
• Physical examinations [Срок оценки: Day 0 -35]
• Nasal examinations [Срок оценки: Day 0 - 35]
• Spirometry (FEV₁ and FVC) [Срок оценки: Day 0-35]
• Triplicate 12-lead ECGs and single 12-lead ECGs [Срок оценки: Day 0 - 35]
• Safety laboratory testing-haematology [Срок оценки: Day 0 - 35]
• Safety laboratory testing-Serum Chemistry [Срок оценки: Day 0- 35]
• Safety laboratory testing-Coagulation [Срок оценки: Day 0 -35]
• Lower respiratory tract symptom score assessments [Срок оценки: Day -7 to 35]

Критерии участия

Критерии включения

Participants must meet all the following inclusion criteria to be eligible to participate in the trial.

• Participants must have a written informed consent obtained prior to any trial related procedure
• Male and female participants aged between 18 to 65 years inclusive, at the time of informed consent.
• Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator.

Additional Inclusion Criteria for Healthy Participants

\- Participants must have a pre-bronchodilator FEV1 ≥80% predicted (using GLI Global predicted values17) and an FEV1 / FVC ratio of >70% absolute at screening.

Additional Inclusion Criteria for Participants with Asthma

• Participants must have a clinical diagnosis of asthma.
• Participants must have either a positive skin prick test with a wheal diameter of ≥3mm greater than control test at 15 minutes, and/or a blood eosinophil count of > 200 cells / µL and/or a FeNO level of > 25 ppb at screening.
• Participants must have a pre-bronchodilator FEV1 ≥65% predicted at screening
• Participants must be using SABA alone or inhaled corticosteroids (ICS) with SABA or ICS with formoterol as reliever therapy, AND/OR regular use of low to mid-dose ICS with or without LABA at a stable dose for at least 3 months prior to randomization to control their asthma.

Part B only

• Participants must have an ACQ-6 score of > 0.75 at screening.
• Participants must have a history of asthma worsening in the previous 2 years, in response to a cold or respiratory infection, as confirmed by the participant.
• Participants must demonstrate seronegativity to RV-A16

Критерии исключения

Exclusion Criteria for all Participants

• History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical trial, expose the participant to undue risk or interfere with the participants ability to successfully conduct the trial, as judged by the Investigator.
• Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the trial at time of screening.
• Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first administration of IMP and/or history of being hospitalized due to epistaxis on any previous occasion.
• Any nasal or sinus surgery within 3 months of the first administration of IMP
• Any signs of upper respiratory tract infection within 6 weeks of screening or prior to first administration of IMP
• Current or previous use of tobacco, nicotine products or e-cigarettes in the past 6 months prior to screening.
• Smoking history of > 5 pack years.

Additional Exclusion Criteria for Participants with Asthma

• Any asthma exacerbation on their current asthma controller medication requiring oral/systemic corticosteroids within 8 weeks of randomization, or that resulted in overnight hospitalization requiring additional treatment for asthma within 3 months of randomization.
• Difficult-to-treat or severe asthma requiring the maintenance use of add-on biologic Type 2 targeted treatments including anti-Immunoglobulin E, anti-IL4 receptor, anti-IL5, anti-IL5 receptor, and anti-Thymic Stromal Lymphopoietin
• History of life-threatening asthma, defined as any asthma episode that required admission to a high-dependency or intensive therapy unit.
• Individuals with close contact to at risk patient groups

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

Великобритания · 2 центра

• Virtus Respiratory Research Ltd — London
• Medicines Evaluation Unit — Manchester

Идентификаторы

NCT: NCT07488897 · RIG_IN_001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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