ANTITNF CHIMERIC MONOCLONAL ANTIBODY IN CROHNS DISEASE

克罗恩病中的抗TNF嵌合单克隆抗体

• 批准号: 6244428
• 负责人: DALE R BACHWICH
• 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/6244428
• 关键词: Crohn's disease; clinical research; dosage; drug screening /evaluation; gastrointestinal disorder chemotherapy; human subject; human therapy evaluation; hybrid antibody; immunotherapy; monoclonal antibody; nonsteroidal antiinflammatory agent; outcomes research; pharmacokinetics; tumor necrosis factor alpha

This is an industry sponsored and initiated phase II study with the primary objective to determine the safety, tolerance, immunogenicity, and pharmacokinetics of a single dose of 5, 10, and 20 mg/kg cA2, as compared to a single dose of placebo in a double-blinded, randomized study in patients with active Crohn's disease.

这是一项由行业赞助并发起的第二阶段研究， 初步目的：确定该疫苗的安全性、耐受性、免疫原性和 5、10和20 mg/kgCA2单次给药的药代动力学比较 在一项双盲随机研究中使用单剂量安慰剂 活动期克罗恩病患者。