在健康参与者中,Cendakimab在不同的器械和不同的注射部位上进行药理动力学表征
Peijin Zhang1, Claudia H M C De Oliveira2, Kyungha Yu2
1Bristol Myers Squibb, Princeton, NJ, USA. Peijin.Zhang@bms.com.
概括
在预装注射器 (PFS) 和自动注射器 (AI) 之间,Cendakimab的药物动力学概况是可比的. 通过人工智能在手臂或大腿中注射显示了相似的,略高于腹部注射的暴露,两种设备都耐受良好.
科学领域:
- 药理动力学和药物输送方法
背景情况:
- 仙达基马布的第三阶段试验使用预填注射器 (PFS),但商用产品将是一个自动注射器 (AI).
- 评估PFS和AI之间的药理动力学 (PK) 可比性对于产品批准和患者使用至关重要.
研究的目的:
- 为了评估通过PFS和AI给药的仙达基马布的药理学可比性.
- 评估不同皮下注射部位 (腹部,上臂,上大腿) 对仙达基马布PK的影响.
主要方法:
- 一个第一阶段,随机,健康成年人的开放标签研究.
- 第1部分:Cendakimab 360mg通过PFS (腹部) 和AI (腹部).
- 第2部分:仙达基马布360毫克通过AI (上臂) 和AI (上大腿).
- 使用ANCOVA分析PK参数 (Cmax,AUC);评估免疫性和安全性.
主要成果:
- 仙达基马布的PK参数 (Cmax,AUC) 在腹部注射时与PFS和AI相似 (90%的CI在80-125%之间).
- 与腹部相比,通过AI在上臂或大腿中施用导致约20%更高的暴露 (Cmax,AUC).
- 无论是PFS还是AI设备都被很好地容忍,由于AE而没有严重的不良事件或停药.
结论:
- 当通过PFS或AI给药时,Cendakimab表现出类似的药理动力学.
- 注射部位 (手臂/大腿) 影响了暴露,与腹部注射相比,观察到的水平更高.
- 仙达基马布是安全的,并且在注射器和注射部位都能很好地耐受.
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