PHASE I STUDY OF BMS188667 IN PSORIASIS VULGARIS

BMS188667 治疗寻常型银屑病的 I 期研究

• 批准号: 6274478
• 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/6274478
• 关键词: CD28 molecule; T lymphocyte; antiallergic agents; clinical research; clinical trial phase I; dosage; drug screening /evaluation; human subject; human therapy evaluation; immunopathology; immunopathology chemotherapy; leukocyte activation /transformation; outcomes research; pharmacokinetics; psoriasis; skin disorder chemotherapy

This was a multi-center, open-label, dose escalation Phase I trial designed to test the safety, pharmacokinetics, and preliminary biologic activity of BMS-188667 (CTLA4Ig) administered as four intravenous injections on Days 1, 3, 16, and 29 to patients with psoriasis vulgaris. The major goals of this study were the determination of: the safety, pharmacokinetics, immunogenicity, and recovery time from biological effects and optimal biologic dose for psoriasis treatment of Bms-188667.

这是一项多中心、开放标签、剂量递增的I期试验 旨在测试安全性、药代动力学和初步生物学 BMS-188667（CTLA 4 Ig）静脉内四次给药的活性 在第1、3、16和29天，对寻常型银屑病患者进行注射。 本研究的主要目的是确定：安全性， 药代动力学、免疫原性和生物学恢复时间 BMS-188667治疗银屑病的疗效和最佳生物剂量。