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在 rhesus 子中,在 14 周内重复给予 rhIL-12:毒性评估

Huiqin Ding^1,2, Huan Qin¹, Jiangang Wang^1,2

¹School of Basic Medical Sciences, Qingdao University, Qingdao, China.

Journal of applied toxicology : JAT

|September 28, 2023

概括

复合人间白蛋白-12 (rhIL-12) 显示出抗瘤潜力,但引起毒性. 在 rhesus 子中重复给予 rhIL-12,发现没有观察到的不良影响水平 (NOAEL) 为 0.5 μg/kg,最高非严重毒性剂量 (HNSTD) 为 7.5 μg/kg.

科学领域:

免疫学免疫学免疫学
毒理学毒理学毒理学
药理学药理学是指药理学的学科.

背景情况:

介质素-12 (IL-12) 通过激活T细胞和NK细胞来表现出抗瘤免疫作用.
由于观察到系统性毒性,IL-12的临床试验已被停止.
需要系统评估重复IL-12的安全性.

研究的目的:

综合评估重复复合人间白内素-12 (rhIL-12) 的毒性和安全性.
评估rhIL-12对 rhesus子免疫系统,器官功能和生命体征的影响.

主要方法:

rhesus 子在0.5,2.5和12.5μg/kg的剂量中接受皮下注射rhIL-12,长达14周.
对于那些表现出不良反应的高剂量组,进行了剂量调整.
监测免疫反应,器官功能指标 (AST,TBIL) 和生命体征.

主要成果:

服用0.5μg/kg的剂量没有显示出毒性.
高剂量导致便,活动减少,贫血和肝酶升高.
在 rhesus 子中观察到对 rhIL-12 的显著免疫反应.

结论:

在3个月内对 rhesus 子进行反复的皮下rhIL-12 给药时,没有观察到的不良影响水平 (NOAEL) 是0.5μg/kg.
最高的非严重毒性剂量 (HNSTD) 确定为7.5μg/kg.
这些发现为rhil-12的潜在治疗开发提供了关键的安全数据.

关键词:

在IL-12中,IL-12是最重要的.通过重复的药物管理.rhesus 子 rhesus 子子子毒性的毒性毒性的毒性毒性动力学毒性动力学

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