Development of Human Anti-Influenza Monoclonal Antibodies for Treatment of Flu

该合同的总体目标和范围是推进用于治疗甲型流感病毒感染的人单克隆抗体（mAb）产品的开发。本合同的工作范围包括非临床、临床前和临床开发活动，以：（1）使用体外和体内方法进行研究以表征和验证先导mAb;（2）开发先导Flu mAb候选物的生产和配制工艺以及分析检测程序，并生产GMP临床材料;（3）开展使能活动，向美国食品药品监督管理局（FDA）提交研究性新药（IND）申请;和（4）进行临床试验以评估安全性、耐受性、药代动力学以及候选药物产品在人体中的有效性证明。

The overall objectives and scope of this contract is to advance the development of human monoclonal antibody (mAbs) products for treatment of Influenza A viral infections. The scope of work for this contract includes nonclinical, preclinical, and clinical development activities to: (1) perform studies to characterize and validate lead mAbs using in vitro and in vivo approaches; (2) develop manufacturing and formulation processes and analytical testing procedures for lead Flu mAb candidates and manufacture GMP clinical materials; (3) perform enabling activities to file the Investigational New Drug (IND) applications with the Food and Drug Administration (FDA); and (4) perform clinical trials to evaluate the safety, tolerability, pharmacokinetics, and the proof of efficacy in humans of the candidate drug products.