NCT06486662已完成1 期
Safety, Tolerability and Pharmacodynamics of Single and Multiple Ascending Doses of OM-85-IN Versus Placebo in Healthy Volunteers, and Patients With Mild Allergic Asthma Using Nasal Allergen Challenge
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- OM Pharma SA
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Percentage of subjects with treatment-emergent adverse events (TEAEs) (including clinically relevant findings from nasal inspection)
研究概览
简要总结
This study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients
详细描述
This study is a double-blind, randomised, placebo-controlled, single and multiple ascending doses, parallel group design study that aims to assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 18 to 55 years. Women will be considered for inclusion if they are:
- •Not pregnant, as confirmed by pregnancy test, and not breastfeeding.
- •Of non-childbearing potential, or
- •Of childbearing potential and using a highly effective method of contraception .
- •Body mass index (BMI) ≥18 and ≤32 kg/m
- •Part II : History of mild asthma that is well controlled with Step 1 treatment according to GINA guidelines 2023 for at least 12 months prior to the Screening Visit, i.e., a history of respiratory symptoms such as wheeze, shortness of breath, chest tightness, cough, and limitation of airflow induced by aeroallergens.
- •Part II: Forced Expiratory Volume in the first second (FEV1) ≥80% of predicted at Screening Visit.
- •Part II : Positive skin prick test to common aeroallergens such as tree, weed, grass or house dust mites within 12 months prior to the Screening Visit
- •Part II : Production of adequate sputum with ≥2 x 105 total non-squamous cells within 12 months to 2 weeks prior to V1A (Day -8)
- •Part II : Positive reaction to Nasal Allergen Challenge (NAC) within 12 months to 2 weeks prior to baseline
- •Exclusion criteria:
- •Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, lung function or electrocardiogram (ECG) at Screening Visit, which, in the opinion of the Investigator, may either put the subject at risk because ofvparticipation in the study or may influence the results of the study, or the subject's ability to participate in the study."
- •Use of prohibited medication prior to study enrolment
- •Part II - Long-term, daily treatment with inhaled corticosteroids.
- •Part II - Exacerbation of asthma defined according to the GINA guideline 2023 as a progressive increase in symptoms of shortness of breath, cough, wheezing or chest tightness and progressive decrease in lung function, i.e., they represent a change from the patient's usual status that is sufficient to require treatment changes within 1 month prior to the Screening Visit.
- •Part II - Concomitant allergies to seasonal aeroallergens which are anticipated to be or become active during study participation.
- •Known allergy to IMP active substance and/or excipients or the challenge agent components.
- •Specific immunotherapy in the past 3 years before Baseline, ongoing treatment with any specific immunotherapy or plan to receive such treatment during study participation.
- •Previous or ongoing treatment with other bacterial lysates and/or probiotics (dietary supplements, medicinal products and/or other health products) within 30 days before Baseline.
- •Patients with pathological skin modifications in the test area (e.g., acute or chronic eczema or skin infections), with disturbed skin reactivity (e.g., hyperkeratosis, ichthyosis, urticaria factitial), or with acute, generalized hypersensitivity reactions.
- •Participation in any other clinical study within 30 days prior to Screening.
- •Past or present disease, which as judged by the Investigator, may affect the outcome of this study.
- •Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies, hepatitis C virus antibodies (HCV-Ab) or human immunodeficiency virus (HIV) antibody at Screening Visit
- •History or presence of clinically significant hypertension
- •History of anaphylactic shock, generalised exanthema, angioedema or hypotension caused by the allergen used for NAC, or any medicinal product in the past.
- •History of drug or alcohol abuse in the past 12 months.
- •Current smokers or ex-smokers for less than 6 months or more than 10 pack years. Current vapers (users of e-cigarette products) or ex-vapers for less than 6 months.
- •Part II : Negative reaction in the baseline NAC
排除标准
- 未提供
研究组 & 干预措施
Part I -Cohort 3
Experimental
OM-85-IN high dose
干预措施: OM-85-IN (Drug)
Part I -Cohort 1
Experimental
OM-85-IN low Dose
干预措施: OM-85-IN (Drug)
Part I -Cohort 1 Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Part I -Cohort 2
Experimental
OM-85-IN medium dose
干预措施: OM-85-IN (Drug)
Part I -Cohort 2 Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Part I -Cohort 3 Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Part II -Cohort 4
Experimental
OM-85-IN dose
干预措施: OM-85-IN (Drug)
Part II -Cohort 4 Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects with treatment-emergent adverse events (TEAEs) (including clinically relevant findings from nasal inspection)
时间窗: 28 days
次要结局
- Part II : Mean difference in fractional exhaled nitric oxide (FeNO) before and after treatment and NAC(28 days)
- Part II : Mean difference of Total Nasal Symptom Score (TNSS points) before and after treatment defined as the arithmetic mean of TNSS collected from pre-Nasal Allergen Challenge (NAC) to 6 hours post-NAC(28 days)
- Part II : Area under the curve (AUC)0-6 hours of Total Nasal Symptom Score (TNSS points) after NAC before and after treatment(28 days)
- Part II : Mean difference of nasal flow by rhinomanometry (Pascal) before and after treatment defined as the arithmetic mean of TNSS collected from pre-Nasal Allergen Challenge (NAC) to 6 hours post-NAC(28 days)
- Part II : Area under the curve (AUC)0-6 of nasal flow by rhinomanometry (Pascal) after NAC before and after treatment(28 days)
- Part II : Mean difference on mannitol dose resulting in ≥15% fall in FEV1 from baseline or ≥10% incremental fall in FEV1 between consecutive mannitol doses after NAC before and after treatment(28 days)
研究者
研究点 (1)
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