First-in-human SAD & MAD trials for MW151, a novel Alzheimer's disease drug candidate that attenuates proinflammatory cytokine dysregulation

Project: Research project

Project Details

Description

The Northwestern University (NU) site for this R01 MPI application under the leadership of the NU principal investigator (NU-PI), Dr. D. Martin Watterson, will work with the University of Kentucky (UK) principal investigator (UK-PI), Dr. Linda Van Eldik, to attain the overall goals of the project. This includes the preparation, validation, storage and distribution of the drug product, the adaptation of extant bioanalytical methods to quantification of parent drug in human biological matrix, and supervision of an outsourced phase 1a SAD and phase 1b MAD clinical study of MW151 that includes pharmacokinetics, pharmacodynamics and safety observations.

The NU site will conduct the following work related to the overall goals of the project:
• NU will monitor bioanalytical and formulation protocols as well as draft and final reports from CROs.
• NU will monitor test results for drug stability.
• NU will monitor CRO analytical methods and supervise report approval and raw data file archiving.
• NU will assist with and monitor regulatory filings.
StatusActive
Effective start/end date2/1/1911/30/20

Funding

  • University of Kentucky (3200002345-19-178//5R01AG061898-02)
  • National Institute on Aging (3200002345-19-178//5R01AG061898-02)

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