DOSE ESCALATION STUDY OF MEDI 507, HUMANIZED MONOCLONAL ANTIBODY CD2

MEDI 507（人源化单克隆抗体 CD2）的剂量递增研究

• 批准号: 6263605
• 负责人: CYNTHIA GUZZO
• 金额: $ 2.51万
• 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: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263605
• 关键词: clinical research; clinical trial phase I; dosage; drug screening /evaluation; human subject; human therapy evaluation; immunotherapy; leukocyte count; monoclonal antibody; pharmacokinetics; psoriasis; skin disorder chemotherapy

This was a multicenter, open label, ascending dose escalation study of MEDI- 507 in patients with plaque psoriasis. The objectives were to describe the safety of MEDI-507; evaluate serum concentrations of different doses; evaluate the pharmacodynamic effects on absolute lymphocyte counts and lymphocyte phenotypes and to describe the clinical grade and histolopathology of psoriasis. The first patient developed a cytokine release reaction during his first infusion. Plans were made to lower the dose, but the study was terminated.

这是一项在斑块状银屑病患者中进行的MEDI- 507多中心、开放标签、剂量递增研究。 目的是描述MEDI-507的安全性;评价不同剂量的血清浓度;评价对绝对淋巴细胞计数和淋巴细胞表型的药效学作用，并描述银屑病的临床分级和组织病理学。 第一例患者在首次输注期间发生细胞因子释放反应。 计划降低剂量，但研究终止。