A Randomized, Double-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics (PK), Safety and Immunogenicity Profile of MB04 (Proposed Etanercept Biosimilar), EU-sourced Enbrel® and US Licensed Enbrel® in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Maximum observed serum concentration (Cmax)
研究概览
简要总结
This is a randomized, double-blind, three-part, two-sequence per part, two-period, single-dose, cross-over study in healthy male volunteers to compare the PK, safety, and immunogenicity of MB04 and EU /US Enbrel®.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
详细描述
The primary objective of the study is to demonstrate PK similarity between MB04 and EU-Enbrel®, between MB04 and US Enbrel® as well as between EU-Enbrel® and US-Enbrel®. Additional PK parameters will be evaluated as secondary endpoints.
Safety and tolerability will be assessed through Adverse Events, clinical laboratory, vital signs, ECGs, and physical examination findings, and any other parameter that is relevant for safety assessment.
The incidence of ADA to etanercept and the neutralizing potential and titre of positive ADA will be reported
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MB04 (etanercept biosimilar)
1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept
干预措施: MB04 (Drug)
US licensed Enbrel (etanercept)
1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept
干预措施: US License Enbrel (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax)
时间窗: Day 1 to day 62
Predose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312, 408, and 600 h post dose
Area under the serum concentration versus time curve (AUC) from time zero to infinity (AUC0-inf)
时间窗: Day 1 to day 62
Predose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312, 408, and 600 h post dose
次要结局
- Terminal half-life (t½)(Day 1 to day 62)
- Time to reach Cmax (tmax)(Day 1 to day 62)
- Incidence of anti-etanercept antibodies (ADA) and neutralizing antibodies (Nab)(Day 1 to day 62)
- AUC from time zero to the last quantifiable concentration (AUC0-last)(Day 1 to day 62)
- Total body clearance (CL/F)(Day 1 to day 62)