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甘特纳鲁马布一次性注射器和自动注射器之间的生物等价性:健康志愿者的随机对照试验
Dietmar Schwab1, Carsten Hofmann1, Nicole Justies1
1Pharma Research and Early Development, Pharmaceutical Sciences, Roc, he Innovation Center, Basel, Switzerland.
Clinical pharmacology in drug development
|February 19, 2026
概括
这项研究表明,通过自动注射器输送的甘鲁马布与通过注射器输送具有生物等价性,在阿尔茨海默病研究中提供了更方便的皮下注射选择.
科学领域:
- 神经科学是一个神经科学.
- 药理学 药理学是指药理学的学科.
- 免疫学 免疫学 免疫学
背景情况:
- 甘特内鲁马布针对阿尔茨海默病 (AD) 的粉样β斑块.
- 关键的渐进I和II级研究没有满足缓慢AD早期临床衰退的初级终点.
- 一种高度的皮下注射 (SC) 配方被开发出来,以方便管理.
研究的目的:
- 评估SC的药理动力学,免疫性和安全性.
- 为了证明自动注射器 (AI) 和一次性注射器 (DS) 之间的生物等价性 (BE).
- 为了确认安全概况与已知的gantenerumab数据保持一致.
主要方法:
- 一个单剂量,平行组研究,包括266名健康参与者.
- 135名参与者通过AI接受了255毫克甘鲁马布;131人通过DS.
- 生物等价性定义为90%,用于Cmax和AUC在0.80-1.25.25之间的几何LS平均比率的CI.
主要成果:
- 在AI和DSSC管理之间证明了生物等价性.
- 对于Cmax,AUC0-inf和AUC0-last的几何LS平均比率 (90%CI) 分别为1.078 (1.006,1.155),1.053 (0.986,1.124) 和1.054 (0.992,1.121).
- 所有的比率都在0.80-1.25的生物等效范围内.
结论:
- 通过自身注射器进行皮下注射的甘鲁马布与通过一次性注射器进行的注射具有生物等价性.
- 自动注射器提供了一种可能更方便的SC注射方法.
- 安全性调查结果与根特纳鲁马布已确定的安全性概况一致.
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