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: 6244451
• 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/6244451
• 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, recovery time from biological effect and optimal diologic 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， 测试的安全性，药代动力学和初步的生物活性 BMS-188667（CTLA 4 Ig）在第10天静脉注射4次 1、3、16和29对寻常型银屑病患者的疗效。 的主要目标 该研究是确定：安全性，药代动力学， 免疫原性、生物效应恢复时间和最佳的生物学特性 BMS-188667治疗银屑病的剂量。