TOLERABILITY/PHARMACOKINETICS OF DAB389 IL 2 IN PATIENTS WITH SEVER PSORIASIS

DAB389 IL 2 在重度银屑病患者中的耐受性/药代动力学

• 批准号: 6244504
• 负责人: CYNTHIA GUZZO
• 金额: $ 2.36万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-17 至 1998-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6244504
• 关键词: clinical research; clinical trials; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; immunotherapy; interleukin 2; outcomes research; pharmacokinetics; psoriasis

This is an open-label, dose-escalating multi-center trial to determine the safety, tolerability, and pharmacokinetic parameter of 3 does of DAB389IL-2 in patients with sever psoriasis. The doses were chosen because previous studies have domonstrated that adverse experiences occur more frequently at higher doses and efficacy has been present at all doses. This protocol explores and lower and varied treatment schedule. Efficacy will also be assessed. A total of forty-five patient will be assigned in a dose escalating manner to one of the 3 dose groups (0.5, 1.5, and 5.0 ug/kg/day). Drug is administered 3 day every other week for 8 weeks.

这是一项开放标签、剂量递增的多中心试验，以确定 3种剂型的安全性、耐受性和药代动力学参数 重度银屑病患者DAB389IL-2的表达剂量是选定的 因为之前的研究已经证明，不良体验会发生 更多的是在更高的剂量下，而且效果一直存在 剂量。该方案探索了降低和变化的治疗方案。 还将对疗效进行评估。 总共45名患者将以递增剂量的方式被分配 至3个剂量组(0.5、1.5和5.0ug/kg/d)之一。毒品是 每隔一周给药3天，疗程8周。