在健康的中国受试者中,对比生物类似物HEC14028和杜拉古 (Trulicity®) 的药理学研究
Xianglei Gao1, Yujing Di2, Yuan Lv1
1Sunshine Lake Pharma Co., Ltd., Dongguan, Guangdong, China.
Clinical and translational science
|April 23, 2024
概括
生物类似药HEC14028在健康的中国男性中显示出与Trulicity® (杜拉古) 的药理学等价性. 两种治疗都显示出可比的安全性和免疫性概况,没有报告严重不良事件.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
- 生物类似药物 生物类似药物
背景情况:
- 特鲁利西蒂 (dulaglutide) 是一种广泛用于治疗2型糖尿病的药物.
- 生物类似药的开发需要严格地与参考产品进行有效性和安全性的比较.
- 对生物类药物HEC14028与杜拉格卢提德的评估对于其监管批准和临床采用至关重要.
研究的目的:
- 为了评估与参考杜拉格卢提德相比HEC14028的药理动力学 (PK) 概况.
- 评估HEC14028在健康人群中的安全性和耐受性.
- 为了确定HEC14028相对于杜拉格卢的免疫性.
主要方法:
- 一个单中心,随机,开放标签,并行控制的I期临床试验.
- 68名健康的中国男性受试者接受了单次0.75毫克的皮下HEC14028或杜拉格卢提德剂量.
- 药物动力学终点包括最大血度 (Cmax) 和曲线下的面积 (AUC0-∞). 安全性评估包括不良事件和免疫性测试.
主要成果:
- 发现HEC14028在药理学上相当于杜拉格卢,Cmax和AUC0-∞比率的90%置信区间处于80-125%的可接受范围内.
- 没有报告3级或更高的治疗引起的不良事件,严重的不良事件或因不良事件而导致的治疗中止.
- 无论是HEC14028还是杜拉格卢提德,都表现出类似的安全性概况,并且没有显示增量免疫性.
结论:
- HEC14028是一种安全有效的杜拉古类生物类似剂,具有可比的药理动力学,安全性和免疫性概况.
- 这些发现支持HEC14028作为一种可行的治疗选择的潜力.
- 可能需要进一步的临床研究来证实在目标患者群体中的疗效.
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