A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 312
- 试验地点
- 18
- 主要终点
- Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
研究概览
简要总结
This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) 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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth
排除标准
- •A medical history and/or condition that is considered significant
- •Clinically significant allergic reactions, hypersensitivity
- •History or current infection of hepatitis B virus (except for past resolved infection), hepatitis C virus, human immunodeficiency virus, or syphilis
- •Active or latent Tuberculosis
- •History of malignancy
- •Previous monoclonal antibody or fusion protein treatment, or current use of any biologic
- •Planning to be pregnant or father a child or donate sperm within 5 month after administration
- •Undergone treatment with an investigational drug or participated in another clinical trial within 90 days or 5 half-lives (whichever is longer)
结局指标
主要结局
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
时间窗: up to Day 71
Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Maximum Serum Concentration (Cmax)
时间窗: up to Day 71
Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
时间窗: up to Day 71
Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
次要结局
- Terminal Elimination Half-life (t1/2)(up to Day 71)
- Time to the Maximum Serum Concentration (Tmax)(up to Day 71)