NCT02089087已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis Patients
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
- 75
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events as a measure of safety and tolerability
研究概览
简要总结
This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous and subcutaneous doses of CFZ533 in healthy subjects and intravenous doses in rheumatoid arthritis patients.
详细描述
This was a Healthy Volunteer only study originally, but after an amendment to protocol, rheumatoid arthritis patients will be starting 7-Mar-2014 and thus, the protocol is now registered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CFZ533 in healthy volunteers
Experimental
CFZ533 single dose in healthy volunteers
干预措施: CFZ533 (Biological)
CFZ533 in rheumatoid arthritis patients
Experimental
CFZ533 single dose in rheumatoid arthritis patients
干预措施: CFZ533 (Biological)
Placebo
Placebo Comparator
Placebo single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with adverse events as a measure of safety and tolerability
时间窗: 7 months
次要结局
- Plasma Pharmacokinetics (PK) of CFZ533: Area Under the Plasma Concentration-time Curve (AUC)(6 months)
- Plasma Pharmacokinetics (PK) of CFZ533: Systemic Clearance from Plasma (CL)(6 months)
- CFZ533 immunogenicity(6 months)
- Plasma Pharmacokinetics (PK) of CFZ533: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)(6 months)
- Plasma Pharmacokinetics (PK) of CFZ533: Apparent Volume of Distribution (Vss)(6 months)
研究者
研究点 (1)
Loading locations...
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