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.

Agency
National Institute of Health (NIH)
Type
Research and Development Contracts (N01)
Project #
272200900060C-5-0-1
Application #
8602501
Study Section
Project Start
2009-08-15
Project End
2014-08-14
Budget Start
Budget End
Support Year
Fiscal Year
2013
Total Cost
$13,677,248
Indirect Cost
Name
Crucell Holland, Bv
Department
Type
DUNS #
415960780
City
Leiden
State
Country
Netherlands
Zip Code
2333 -CN