A Single-Center, Double-Blinded, Placebo-Controlled, Phase 1 Evaluation of the Safety of Ragweed Mix Given in Four Monthly Doses by Intralymphatic Node Injections for Inducing Tolerance in Subjects With Ragweed Induced Allergic Conjunctivitis and Allergic Rhinitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale
研究概览
简要总结
A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic injections of 2 different dose levels of the investigational short and tall ragweed product. Biomarkers will be assessed at baseline and at multiple time points post-treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 16 and 65 years old
- •Seasonal Allergic Conjunctivitis (with or without Allergic Rhinitis) to ragweed pollen
- •Positive skin test reaction at screening visit to short ragweed extract
- •Avoid disallowed medications
- •Females of childbearing potential must have pregnancy test and must agree to use an acceptable method of birth control
- •Have blood and urine analysis within normal limits
- •Manifest a positive reaction to a conjunctival allergen challenge with ragweed pollen
- •Have a specific IgE ≥ 0.70 kU/L to short ragweed
排除标准
- •Have ocular or nasal conditions that could affect subject safety or trial parameters
- •Have a presence of an active sinus, nasal, or ocular infections
- •Have had allergy immunotherapy to ragweed pollen
- •Have a compromised lung function ≤80% of predicted
研究组 & 干预措施
Concentration 1: Short and Tall Ragweed Mix
干预措施: Dose Level 1 (Biological)
Concentration 2: Short and Tall Ragweed Mix
干预措施: Dose Level 2 (Biological)
Placebo: Saline with 0.4% Phenol
干预措施: Placebo (Biological)
结局指标
主要结局
Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale
时间窗: 47 weeks
Adverse events (reported, elicited and observed)
时间窗: 47 weeks
Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale
时间窗: 47 weeks
Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale
时间窗: 47 weeks
Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale
时间窗: 47 weeks
次要结局
未报告次要终点