候选生物类似物CTP55与参考secukinumab的药理动力学和安全性:一个三臂,随机,双盲,单剂量,多中心,I期研究
Tomoko Hasunuma1, Michio Yagi2, Noboru Nakamichi3
1Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
候选生物类似剂CT-P55在健康的日本男性中显示出与欧盟批准和美国许可的secukinumab相当的药理动力学,安全性和免疫性. 这些发现支持CT-P55作为可比的生物类药物选择.
科学领域:
- 药理学 药理学是指药理学的学科.
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 这是首次对人类进行评估生物类似CT-P55.5的研究.
- 与欧盟批准和美国许可的secukinumab.com进行比较.
研究的目的:
- 评估CT-P55.5的药理动力学,安全性和免疫性.
- 确定与参考secukinumab产品的生物等价性.
主要方法:
- 第1阶段,三臂,双盲,并行组研究.
- 在日本的健康成年男性中,单次150毫克的皮下剂量.
- 主要终点:AUC0-inf和Cmax.
主要成果:
- CT-P55显示了相当的PK (AUC0-inf,Cmax) 在80-125%的等效率范围内.
- 具有相似的安全性概况,大多数是1/2级不良事件.
- 免疫性低且可比;没有检测到中和抗体.
结论:
- 在药理学上,CT-P55与欧盟和美国的secukinumab相当.
- 观察到可比的安全性和免疫性概况.
- 一般化可能仅限于亚洲男性.
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