A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 176
- 试验地点
- 3
- 主要终点
- Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
研究概览
简要总结
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject (male or female) between the ages of 18 and 55 years.
- •Subject with a body weight of > 40 kg and ≤ 90 kg and a BMI between 18.0 kg/m2 and 32.0 kg/m2(both inclusive).
- •Subject with a total IgE level of ≤ 100 IU/mL.
排除标准
- •Subject has a medical history and/or current presence of disease including one or more of the allergic reaction.
结局指标
主要结局
Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
时间窗: up to day 127
Area Under the concentration-time Curve from time zero to infinity (AUC0-inf) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Pharmacokinetic Outcome Measures [Cmax] for Part 2
时间窗: up to day 127
Maximum serum concentration (Cmax) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Pharmacokinetic Outcome Measures [AUC0-last] for Part 2
时间窗: up to day 127
Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
次要结局
- Pharmacodynamic Outcome Measures [Tmin of Free IgE] for Part 1 & Part 2(Up to day 127)
- Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2(up to day 127)
- Pharmacodynamics Outcome Measures [Cmin of Free IgE] for Part 1 & Part 2(up to day 127)
- Pharmacodynamic Outcome Measures [Tmax of Total IgE] for Part 1 & Part 2(up to day 127)
- Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2(up to day 127)
- Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2(up to day 127)