A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Adalimumab (SB5, EU Sourced Humira® and US Sourced Humira®) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 189
- 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, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.
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
- Single (Participant)
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 subjects
- •Have 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 investigational product formulation or comparable drugs
- •Active or latent Tuberculosis or who have a history of Tuberculosis
- •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 4 weeks 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 4 weeks or 10 half-lives of the medication prior to investigational product administration
研究组 & 干预措施
EU sourced Humira®
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
干预措施: SB5 (Biological)
SB5
SB5, single dose of 40 mg via subcutaneous injection (study drug)
干预措施: EU sourced Humira® (Biological)
EU sourced Humira®
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
干预措施: US sourced Humira® (Biological)
US sourced Humira®
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
干预措施: US sourced Humira® (Biological)
US sourced Humira®
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
干预措施: EU sourced Humira® (Biological)
SB5
SB5, single dose of 40 mg via subcutaneous injection (study drug)
干预措施: SB5 (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 1680 hours post-dose
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
时间窗: 0 to 1680 hours post-dose
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Maximum Serum Concentration (Cmax)
时间窗: pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
次要结局
- Time to Cmax (Tmax)(pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose)