NCT05188378Unknown1 期
A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 发起方
- Celltrion
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Primary objective
研究概览
简要总结
A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
详细描述
Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.
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
- •Body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 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, hepatitis C virus, human immunodeficiency virus, or syphilis
- •Active or latent Tuberculosis
- •History of malignancy
- •Previous exposure to tocilizumab or any drug that targets IL-6
结局指标
主要结局
Primary objective
时间窗: up to Day 43
To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf)
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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