NCT01152619已完成1 期
A Multi-center, Randomized, Observer-blind, Placebo-controlled Safety and Tolerability Study of Repeated Administration of Two Dose Levels of RO4989991 Administered Subcutaneously to Patients With Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Assessment of the safety and tolerability of RO4989991
研究概览
简要总结
This multi-center, randomized, observer-blinded, placebo-controlled study will evaluate the safety and tolerability of subcutaneous doses of RO4989991 in patients with allergic rhinitis who are otherwise healthy. The anticipated time on study treatment is 2 weeks.
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
- Double (Participant, 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
- •Adult patients, 18-65 years of age, inclusively
- •A history of allergic rhinitis diagnosed by a physician, but otherwise healthy
- •A positive skin prick test to at least one standardized allergen at screening
- •A body mass index (BMI) between 18 and 32 kg/m2, inclusively
排除标准
- •History or presence of any respiratory disease or condition other than allergic rhinitis
- •Use of prescription medication or herbal remedies within 14 days of dosing the study drug
- •Use of over-the-counter (OTC) medications within 7 days of dosing the study drug
- •Acute infection (including viral infections) 6 weeks (8 weeks for respiratory infections) preceding dosing or any ongoing chronic infection
- •Positive test for human immunodeficiency virus (HIV) or hepatitis B or C
研究组 & 干预措施
1
Experimental
干预措施: RO4989991 (Drug)
2
Experimental
干预措施: RO4989991 (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of the safety and tolerability of RO4989991
时间窗: 24 weeks
次要结局
- Assessment of pharmacokinetics(24 weeks)
研究者
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