A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 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)
研究组 & 干预措施
Cohort 1
Birch-SPIRE or placebo, 2 weeks apart
干预措施: Placebo (Biological)
Cohort 2
Birch-SPIRE or placebo, 2 weeks apart
干预措施: Placebo (Biological)
Cohort 3
Birch-SPIRE or placebo, 2 weeks apart
干预措施: Placebo (Biological)
Cohort 4
Birch-SPIRE or placebo, 2 weeks apart
干预措施: Placebo (Biological)
Cohort 5
Birch-SPIRE or placebo, 2 weeks apart
干预措施: Placebo (Biological)
Cohort 3
Birch-SPIRE or placebo, 2 weeks apart
干预措施: Birch-SPIRE (Biological)
Cohort 5
Birch-SPIRE or placebo, 2 weeks apart
干预措施: Birch-SPIRE (Biological)
Cohort 4
Birch-SPIRE or placebo, 2 weeks apart
干预措施: Birch-SPIRE (Biological)
Cohort 2
Birch-SPIRE or placebo, 2 weeks apart
干预措施: Birch-SPIRE (Biological)
Cohort 1
Birch-SPIRE or placebo, 2 weeks apart
干预措施: Birch-SPIRE (Biological)
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)