拟议的生物类似乌斯特基努马布 (BFI-751) 的药理动力学概况:随机第一阶段试验的结果
Jeffrey N Hausfeld1, Rodeina Challand1, Kristi McLendon2
1BioFactura, Inc., MD, USA.
Clinical pharmacology in drug development
|July 24, 2023
概括
生物工厂是生物工厂.
科学领域:
- 药理学和制药科学 药理学和制药科学
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 生物制造商BioFactura开发了BFI-751,这是一个拟议的生物类似于ustekinumab的药物.
- 乌斯特基努马布是一种用于自身免疫性疾病的生物疗法.
- 生物仿制药有可能增加患者获取和降低医疗保健成本.
研究的目的:
- 为了比较BFI-751的药理动力学特征,安全性和免疫性,与欧盟和美国的参考 ustekinumab.
- 评估欧盟和美国的乌斯特基努马布基准产品之间的相似性.
- 评估BFI-751在人类第一次临床试验中.
主要方法:
- 一个多中心,随机,双盲,三平行组研究 (NCT04843631).
- 健康的受试者接受了BFI-751,EU ustekinumab或美国 ustekinumab的单次皮下45毫克剂量.
- 评估了关键的药理动力学参数 (AUC,Cmax),安全性,耐受性和免疫性.
主要成果:
- 所有双对比都满足了药理学参数 (AUC,Cmax) 的生物等价性标准,90%的置信区间在80%-125%.
- 在BFI-751和参考ustekinumab之间没有观察到安全性和耐受性概况的显著差异.
- 在所有组中,治疗引起的不良事件通常为轻度至中度.
结论:
- BFI-751与欧盟和美国ustekinumab参考产品的药理学相似性得到证明.
- BFI-751的安全性和耐受性表现与乌斯特基努马布相似.
- 这些发现支持BFI-751作为一种潜在的ustekinumab生物类药物.
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