A Randomised, Single-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel® and US Sourced Enbrel®) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.
详细描述
- Part A: Comparison between SB4 and EU sourced Enbrel
- Part B: Comparison between SB4 and US sourced Enbrel
- Part C: Comparison between EU sourced Enbrel and US sourced Enbrel
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •Have a body weight between 60 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.
排除标准
- •history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.
- •active or latent Tuberculosis or who have a history of TB.
- •history of invasive systemic fungal infections or other opportunistic infections
- •systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
- •serious infection associated with hospitalisation and/or which required intravenous antibiotics
- •history of and/or current cardiac disease
- •have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
- •Intake medication with a half-life > 24 h within 1 month or 10 half-lives of the medication prior to the first administration of IP.
研究组 & 干预措施
EU sourced Enbrel and SB4 in Part A
EU sourced Enbrel followed by SB4
干预措施: SB4 (Biological)
SB4 and EU sourced Enbrel in Part A
SB4 followed by EU sourced Enbrel
干预措施: SB4 (Biological)
SB4 and EU sourced Enbrel in Part A
SB4 followed by EU sourced Enbrel
干预措施: EU sourced Enbrel (Biological)
EU sourced Enbrel and SB4 in Part A
EU sourced Enbrel followed by SB4
干预措施: EU sourced Enbrel (Biological)
SB4 and US sourced Enbrel in Part B
SB4 followed by US sourced Enbrel
干预措施: US sourced Enbrel (Biological)
US sourced Enbrel and SB4 in Part B
US sourced Enbrel followed by SB4
干预措施: US sourced Enbrel (Biological)
EU and US sourced Enbrel in Part C
EU sourced Enbrel followed by US sourced Enbrel
干预措施: EU sourced Enbrel (Biological)
EU and US sourced Enbrel in Part C
EU sourced Enbrel followed by US sourced Enbrel
干预措施: US sourced Enbrel (Biological)
US and EU sourced Enbrel in Part C
US sourced Enbrel followed by EU sourced Enbrel
干预措施: EU sourced Enbrel (Biological)
US and EU sourced Enbrel in Part C
US sourced Enbrel followed by EU sourced Enbrel
干预措施: US sourced Enbrel (Biological)
SB4 and US sourced Enbrel in Part B
SB4 followed by US sourced Enbrel
干预措施: SB4 (Biological)
US sourced Enbrel and SB4 in Part B
US sourced Enbrel followed by SB4
干预措施: SB4 (Biological)
结局指标
主要结局
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
时间窗: 0 to 480 hours post-dose
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Maximum Serum Concentration (Cmax)
时间窗: 0 to 480 hours post-dose
pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose.
次要结局
- Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)(0 to 480 hours post-dose)
- Time to Cmax (Tmax)(0 to 480 hours post-dose)