PHASE 2A STUDY OF RPAF AH IN ALLERGEN CHALLENGE IN MILD ASTHMATICS

RPAF AH 在轻度哮喘患者过敏原挑战中的 2A 期研究

• 批准号: 6113126
• 负责人: WILLIAM REED HENDERSON
• 金额: $ 0.39万
• 依托单位: UNIVERSITY OF WASHINGTON
• 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/6113126
• 关键词: allergens; asthma; clinical research; dosage; human subject; human therapy evaluation; intravenous administration; pharmacokinetics; platelet activating factor; respiratory disorder chemotherapy

Platelet-activating factor (PAF) has biologic activities pertinent to asthma pathogenesis. PAF induces bronchoconstriction, increases bronchial hyperreactivity and vascular permeability, and stimulates bronchial mucus secretion and eosinophil infiltration of airways. The actions of PAF are modulated by the plasma protein PAF acetylhydrolase (PAF-AH) that hydrolyzes PAF to biologically inactive lyso-PAF. We have found that recombinant PAF-AH suppresses PAF-induced inflammation in vivo in a murine model of human asthma. This Phase 2a study will evaluate the clinical safety of rPAF-AH, administered intravenously as a single dose to subjects with stable, mild asthma. This study will also determine the effect of rPAF-AH on allergen-induced early and late phase asthmatic responses.

血小板活化因子（PAF）具有与哮喘发病相关的生物学活性。 PAF诱导支气管收缩，增加支气管高反应性和血管通透性，并刺激支气管粘液分泌和气道嗜酸性粒细胞浸润。 PAF的作用受血浆蛋白PAF乙酰水解酶（PAF-AH）的调节，PAF-AH将PAF水解为生物学上无活性的溶血PAF。 我们发现重组PAF-AH在人哮喘小鼠模型中抑制PAF诱导的体内炎症。 这项2a期研究将评价rPAF-AH的临床安全性，rPAF-AH单次静脉给药，用于稳定的轻度哮喘受试者。 本研究还将确定rPAF-AH对变应原诱导的早期和晚期哮喘反应的影响。