TOLERABILITY/PHARMACOKINETICS OF DAB389 IL 2 IN PATIENTS WITH SEVERE 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: 6274518
• 负责人: CYNTHIA GUZZO
• 金额: $ 2.5万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-15 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274518
• 关键词: clinical research; clinical trials; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; immunotherapy; interleukin 2; pharmacokinetics; psoriasis

This is an open-label, dose-escalating multi-center trial to determine the safety, tolerability, and pharmacokinetic parameter of 3 doses of DAB389IL-2 in patients with severe psoriasis. The doses were chosen because previous studies have demonstrated that adverse experiences occur more frequently at higher doses and efficacy has been present at all doses. This protocol explores a lower and varied treatment schedule. Efficacy will also be assessed. A total of forty-five patients 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 days 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种剂量的安全性、耐受性和药代动力学参数 DAB389IL-2 治疗严重银屑病患者。 剂量已选定 因为之前的研究表明，不良经历 在较高剂量下更频繁地发生并且功效已在 所有剂量。 该方案探索了一种较低且多样化的治疗方法 日程。 还将评估功效。 总共 45 名患者将被分配剂量递增的剂量 方式至 3 个剂量组之一（0.5、1.5 和 5.0 ug/kg/天）。 药品 每隔一周给药 3 天，持续 8 周。