NCT02478060已完成2 期
A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Safety of Birch-SPIRE administrations measured by Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 65 years;
- •Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen
- •Birch IgE ≥ 0.35 kU/L
- •Positive skin prick test to whole birch allergen
排除标准
- •Any past history of asthma
- •FEV1 < 80% of predicted
- •History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food
- •Acute phase skin response to whole birch allergen with a mean wheal diameter > 50mm
- •Administration of adrenaline (epinephrine) is contraindicated
- •History of severe drug allergy or anaphylactic reaction to food.
- •History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
结局指标
主要结局
Safety of Birch-SPIRE administrations measured by Adverse Events
时间窗: Up to 16 weeks after start of dosing
次要结局
- Measurement of IgE as a Pharmacodynamic parameter(Up to 9 months after start of dosing)
- Conjunctival Provocation Test as a Pharmacodynamic parameter(Up to 9 months after start of dosing)
- Skin Prick Testing as a Pharmacodynamic parameter(Up to 9 months after start of dosing)
研究者
研究点 (2)
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