NCT02806219已完成1 期
Open-label, Single-center, Randomized, Parallel Group, Single-dose, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled syringe (PFS, reference) or injected by means of a injection device (e-Device, test).
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
- •Subject is male or female and between 18 and 55 years of age at Screening.
- •Subject is in good physical and mental health status determined on the basis of the medical history and a general clinical examination.
- •Subject has no evidence of active or inactive Tuberculosis (TB).
- •Female subjects of childbearing potential should have a negative pregnancy test at study entry and should be using a medically accepted method of contraception during the entire duration of the study and for 10 weeks after the final dose of CZP.
- •Female subjects who are postmenopausal for at least 2 years and have a serum follicle stimulating hormone (FSH) level >40mIU/mL at the Screening Visit, or have undergone a hysterectomy, bilateral tubal ligation, and/or bilateral ovariectomy, or have a congenital sterility are considered not of childbearing potential.
排除标准
- •Subject receiving any live (includes attenuated) vaccination or immunoglobulins within 56 days preceding the CZP injection.
- •Subject has taken any drugs (including over-the-counter medications) within 56 days preceding the CZP injection (with the exception of those noted in Section 7.8.1.).
- •Subject is known to be intolerant to pegol.
- •Subject has previously received CZP.
- •Subject has received TNFα-inhibitors within 12 months or other biologic within 6 months before randomization into the study.
- •Subject has an active or chronic/latent infection including TB, hepatitis C virus (HCV), hepatitis B core antigen (HBc), or human immunodeficiency virus (HIV).-- Subject has symptomatic herpes zoster infection (shingles) within 6 months prior to Screening.
- •Subject has chronic, serious, opportunistic recurring infection or condition within 6 months prior to Screening.
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Area under the CZP plasma concentration-time curve from time 0 to infinity (AUC)
时间窗: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Area under the CZP plasma concentration-time curve from time 0 to last observed quantifiable concentration (AUC(0-t))
时间窗: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
次要结局
- Time of observed Cmax (tmax)(Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.)
- Terminal elimination half-life (t1/2)(Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.)
- Apparent total body clearance (CL/F)(Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.)
- Apparent volume of distribution (Vz/F)(Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.)
研究者
研究点 (1)
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