NCT01596712已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Following Subcutaneous Injections of QGE031 in Japanese Atopic Male Subjects
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
- 209
- 试验地点
- 1
- 主要终点
- Number of Patients with Adverse Events
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the eligibility of Japanese patients in subsequent clinical studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male Japanese subjects who are atopic as determined by an in vitro test (CAP-RAST or MAST test)
- •Serum IgE level must be equal to or greater than 30 IU/mL at screening.
排除标准
- •Poorly controlled asthma i.e. symptoms of asthma (daytime or night-time) or use of short-acting beta agonist for relief of asthma (except with exercise) more than once a week
- •Worsening of asthma signs and symptoms prompting a medical intervention within 1 year prior to dosing
- •Severe atopic dermatitis within 1 year prior to dosing, defined by a history of eruption with severe inflammation such as erythema, papule, erosion, infiltration and lichen
- •Severe allergic rhinitis strongly disturbing daily life within 1 year prior to dosing
- •Severe allergic conjunctivitis (e.g., episodes of giant papillary, limbal proliferation, shield ulcer) within 1 year prior to dosing
- •Prior use of Xolair® or other anti-IgE antibodies
- •Concomitant use of allergy vaccination therapy
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
QGE031 Dose 1
Experimental
QGE031 Dose 1: subcutaneous injection, single dose
干预措施: QGE031 (Drug)
QGE031 Dose 2
Experimental
QGE031 Dose 2: subcutaneous injection, single dose
干预措施: QGE031 (Drug)
QGE031 Dose 3
Experimental
QGE031 Dose 3: subcutaneous injection, single dose
干预措施: QGE031 (Drug)
Placebo
Placebo Comparator
Placebo to QGE031 : subcutaneous injection, single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients with Adverse Events
时间窗: Day 113
Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs and other safety assessments.
次要结局
- QGE031 serum concentration(Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113)
- Free and total IgE serum concentrations(Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113)
- Immunogenicity (Anti-QGE031 antibody in serum)(Pre-dose, Days 29, 57 and 113)
- FcεRI expression and IgE binding on basophiles(Pre-dose, 2, 24, 48, 96 h post-dose; Days 8, 15, 22, 29, 43, 57, 71, 85, 99, and 113)
研究者
研究点 (1)
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