NCT03446976已完成1 期
A Phase 1, Randomized, Open-label, Single-dose, Two-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of the Pre-filled Syringe and Auto-injector of CT-P13 in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects.
研究概览
简要总结
This study compares two administration methods of CT-P13. Half of participants will receive CT-P13 by pre-filled syringe while the other half will receive CT-P13 by auto-injector.
详细描述
This is a Phase I Study to Compare Pharmacokinetics and Safety between CT-P13 SC Pre-filled Syringe and CT-P13 SC Auto-injector in Healthy Subjects. A total of 218 healthy subjects will be enrolled.
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
- None
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 male and female subject
- •Subject voluntarily agrees to participate in this study
排除标准
- •Subject with medical history and/or condition
- •Female who is pregnant or breastfeeding, or childbearing potential.
研究组 & 干预措施
CT-P13 SC Auto-injector
Experimental
CT-P13 SC Auto-injector
干预措施: CT-P13 SC Auto-injector (Biological)
CT-P13 SC Pre-filled Syringe
Experimental
CT-P13 SC Pre-filled Syringe
干预措施: CT-P13 SC Pre-filled Syringe (Biological)
结局指标
主要结局
To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects.
时间窗: over 12 weeks
Pharmacokinetics will be assessed by AUC
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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