NCT01568762已完成1 期
A Randomized, Double-blind, Placebo Controlled Study to Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 (Sequential Administration of a Fixed Dose of VAK694 and Single Ascending Doses of QAX576) in Patients With Well-controlled Mild to Moderate Asthma
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
- 50
- 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 is designed to compare the safety, tolerability, and pharmacokinetics of QBX258 (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in patients with well-controlled mild to moderate asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects age 18-60 years (inclusive)
- •Well controlled mild to moderate atopic asthma
- •Female subjects must be post-menopausal or surgically sterile
- •Male subjects must be using two methods of contraception
- •Subjects must have a positive skin prick test to one or more common airborne allergen
排除标准
- •Participation in any clinical investigation or use of other investigational drugs at time of enrollment
- •A history of clinically significant ECG abnormalities
- •History of malignancy of any organ system
- •Smokers (use of tobacco products in the previous 3 months)
- •Use of prescription drugs other than those required for control and relief of asthma
- •Use of oral steroids within 12 weeks prior to dosing
- •FEVI < 80% predicted at screening or baseline
- •Use of albuterol more than twice a week for relief of asthma
- •Patients suffering from active hay fever at baseline or likely to require treatment during the study
- •History of chronic respiratory disease other than asthma or chronic allergic rhinitis
- •Emergency room visit within 6 weeks of screening due to asthma
- •Hospitalization for asthma in the last year
- •History of intubation/assisted ventilation for asthma in the last 5 years
- •Administration of live vaccines within the preceding month
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
VAK694 Placebo
Placebo Comparator
VAK694 placebo was administered as a one hour intravenous infusion
干预措施: VAK694 placebo (Drug)
VAK694
Experimental
VAK694 was administered as a 1 hour intravenous infusion
干预措施: VAK694 (Drug)
QAX576
Experimental
QAX576 was administered intravenously as a 2 hour infusion
干预措施: QAX576 (Drug)
QAX576 placebo
Placebo Comparator
QAX576 placebo was administered as a 2 hour intravenous infusion
干预措施: QAX576 placebo (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: 100 days
Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs
次要结局
- Concentration of serum anti-VAK694 antibodies(Pre-dose, Day 71, 85 and 100)
- Concentration of serum anti-QAX576 antibodies(Pre-dose, Day 71, 85 and 100)
- Area under the serum concentration curve for VAK694(Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100)
- Area under the serum concentration curve for QAX576(Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100)
- Change in interleukin concentrations(Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100)
研究者
研究点 (1)
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