38 Day Toxicity Study of Subcutaneous Asparaginase in Beagle Dogs

比格犬皮下注射天冬酰胺酶的 38 天毒性研究

• 批准号: 10563091
• 负责人: Charles Ralph Krikorian
• 金额: $ 25万
• 依托单位: ASSISI RESEARCH LABORATORIES, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10563091
• 关键词: 38; Day; Toxicity; Study; Subcutaneous

February 2022 Project Summary/Abstract Asparaginase is MUMS Designated for the induction of remission in multicentric lymphoma in dogs. To date, toxicity data regarding the use of asparaginase in dogs has not been available. As part of the approval process for asparaginase as a new animal drug, a Target Animal Safety Study has been proposed to, and concurred with by, the Center for Veterinary Medicine of the Food and Drug Administration. The study involves the subcutaneous administration of asparaginase to thirty-two (16/sex) dogs, randomly assigned to 4 groups of 4/sex/group to determine the toxicity of asparaginase when given once weekly for 6 doses (Days 1, 8, 15, 22, 29 and 36) ranging from 0 IU/kg/dose (control animals), to 400, 800, or 1600 IU/kg/dose. Animals will be terminated and necropsied on Day 38. Local and systemic effects of asparaginase administration will be catalogued both in-life and at necropsy. In addition, because asparaginase is a heterologous protein (it is derived from E. coli), study animals will be observed each day of the study for signs of hypersensitivity reactions and blood samples will be collected throughout the study period from all study animals for subsequent determination of the presence of anti-drug antibodies if hypersensitivity reactions are detected by in-life observations or at necropsy. Ultimately, the data collected by this study will be presented, in summary fashion, in the Animal Safety portion of the approved product prescribing information for the benefit of prescribing veterinarians.

2022年2月 项目摘要/摘要 天冬酰胺酶是指定用于诱导多中心淋巴瘤缓解的妈妈 狗。迄今为止，尚未获得有关在狗中使用天冬酰胺酶的毒性数据。作为 天冬氨酸酶作为一种新动物药物的批准过程，目标动物安全研究 已提议并同意食物兽医医学中心，并同意 药物管理局。该研究涉及地下给药天冬酰胺酶 32（16个/性）狗，随机分配给4组/性别/组的4组，以确定毒性 每周一次以6剂（第1、8、15、22、29和36天）给予天冬酰胺酶 0 IU/kg/剂量（对照动物）为400、800或1600 IU/kg/剂量。动物将被终止， 在第38天被颗粒状。天冬氨酸酶给药的局部和全身效应将是 对生命和尸检都进行了分类。另外，由于天冬酰胺酶是一种异源蛋白 （它是从大肠杆菌中得出的），研究动物每天都会观察到动物 在整个研究期间，将收集超敏反应和血液样本 所有研究动物随后确定抗药物抗体的存在 通过生命观测或尸检检测到超敏反应。最终，数据 该研究收集 批准的产品处方信息是为了开处方兽医。