NCT00813774已完成1 期
Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Area under the plasma drug concentration-time curve from time 0 to the last quantifiable point (AUC(0-t),)
研究概览
简要总结
To compare the bioavailability of a single dose of certolizumab pegol solutions given subcutaneously either by one of the three formulations and to investigate safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 volunteers aged between 18 and 55
- •Body Mass Index (BMI) between 18 and 30 kg/m2 with normal laboratory data
- •negative for Tuberculosis test
- •normal Electrocardiogram (ECG)
- •adequate contraception for females
- •given informed consent
排除标准
- •Any significant abnormality in medical history, physical examination, laboratory testing
- •Intake of concomitant medication
- •smoking more than 10 cigarettes per day
- •alcohol or drug abuse
- •pregnancy or breast feeding
- •history of tuberculosis
- •participation in another trial within 3 months prior to this study
- •previous administration of certolizumab pegol
研究组 & 干预措施
Pre-filled Syringe
Experimental
Pre-filled syringe (test)
干预措施: Certolizumab pegol (Biological)
Liquid
Experimental
Liquid Formulation (test)
干预措施: Certolizumab pegol (Biological)
Reference
Active Comparator
Lyophilized formulation (reference)
干预措施: Certolizumab pegol (Biological)
结局指标
主要结局
Area under the plasma drug concentration-time curve from time 0 to the last quantifiable point (AUC(0-t),)
时间窗: PK samples: from pre-dose to Week 12
Maximum plasma concentration (Cmax)
时间窗: PK samples: from pre-dose to Week 12
Area under the plasma drug concentration-time curve from time 0 to infinity (AUC)
时间窗: PK samples: from pre-dose to Week 12
次要结局
- Apparent terminal elimination rate constant (λz)(PK samples: from pre-dose to Week 12)
- Apparent terminal elimination half-life (t1/2)(PK samples: from pre-dose to Week 12)
- Time corresponding to Cmax (tmax)(PK samples: from pre-dose to Week 12)
- Apparent Total body clearance (CL/F)(PK samples: from pre-dose to Week 12)
- Apparent Volume of distribution (Vz/F)(PK samples: from pre-dose to Week 12)
- Number of subjects with anti-certolizumab pegol antibody plasma level >2.4 units/mL(PK samples; from pre-dose to Week 12)
- Time point where log-linear elimination phase begins (TLIN )(PK samples: from pre-dose to Week 12)
- Lowest quantifiable concentration time (LQCT)(PK samples: from pre-dose to Week 12)
- Extrapolated portion of the AUC (AUC_ext )(PK samples; from pre-dose to Week 12)
研究者
研究点 (2)
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