相关实验视频

Updated: Jun 10, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

静脉注射候选生物类似CT-P47和参考托西利祖马布的药理动力学和安全性:一项随机,双盲,第一阶段研究

Miwa Haranaka¹, Takashi Eto¹, Takanori Tanaka²

¹SOUSEIKAI Hakata Clinic, Fukuoka, Japan.

Journal of clinical pharmacology

|October 17, 2024

概括

在健康的日本成年人中,CT-P47,是托西利祖马布的生物类似剂,证明了与欧盟和美国许可的托西利祖马布的药理学等价性和可比安全性. 这一第一阶段研究证实CT-P47是一种可行的生物类似药选择.

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:

托西利祖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.
CT-P47是一种拟议的生物类似物,用于参考cilizumab.

研究的目的:

评估CT-P47与欧盟和美国许可的托西利祖马布相比的药理动力学 (PK) 相当性.
评估CT-P47在健康成年人中的安全性和免疫性.

主要方法:

一项为期12周,随机,双盲,并行设计的第一阶段研究,对133名健康的日本成年人 (18-55岁) 进行.
参与者接受了CT-P47,欧盟-托西利祖马布或美国-托西利祖马布 (1:1:1比率) 的单次8mg/kg静脉注射剂量.
主要PK终点包括AUC和Cmax;安全性和免疫性是次要终点.

主要成果:

证明了药物动力学等价性,主要PK变量的90%置信区间处于0.80-1.25等价率范围内.
治疗出现的不良事件 (TEAE) 的发生率,主要是中性粒细胞数量的减少,在所有组中都是可比的.
没有报告TEAE引起的严重TEAE,死亡或停止治疗;观察到抗药抗体 (ADA) 和中和抗体 (NAbs) 的低率.

结论:

CT-P47在药物动力学上与欧盟和美国许可的托西利祖马布具有相当性.
CT-P47显示了与参考产品相比,可比的安全性和免疫性特征.
这些发现支持CT-P47作为托西利祖马布的潜在生物类药物.

关键词:

在CT-P47中使用.生物类似药物生物类似药物免疫性免疫性免疫性药物动力学药物动力学在安全方面,安全是安全的.这就是为什么tocilizumab.

更多相关视频

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

Single-cell Analysis of Immunophenotype and Cytokine Production in Peripheral Whole Blood via Mass Cytometry

Single-cell Analysis of Immunophenotype and Cytokine Production in Peripheral Whole Blood via Mass Cytometry

Published on: June 26, 2018

相关概念视频

Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...