At 8 a.m. on Monday, March 13, 2006, eight healthy young menentered a trial of a drug under development by the small Germanimmunotherapeutics company TeGenero. Six of the volunteers wereassigned to receive active drug, and two were to receive placebo.The trial was being conducted for TeGenero by Parexel, a largecontract research organization, at its facility at NorthwickPark Hospital outside London. The six volunteers were to bethe first humans to receive TGN1412, a humanized monoclonalantibody designed as an agonist of the CD28 receptor on T lymphocytes,which stimulates the production and activation of . . . [Full Text of this Article]
Source Information
Dr. Wood is a professor of medicine and pharmacology at Vanderbilt University School of Medicine, Nashville. Dr. Darbyshire is the director of the Clinical Trials Unit of the Medical Research Council, London.
An interview with Dr. Wood can be heard at www.nejm.org.
This article has been cited by other articles:
Kimmelman, J.
(2007). Ethics at Phase 0: Clarifying the Issues. J Law Med Ethics
35: 727-733
Bertino, J. S. Jr., Greenberg, H. E., Reed, M. D.
(2007). Response to Comments on ACCP Position Statement on Microdosing. J Clin Pharmacol
47: 1597-1598
[Full Text]
Levin, L. A., Palmer, J. G.
(2007). Institutional Review Boards Should Require Clinical Trial Registration. Arch Intern Med
167: 1576-1580
[Full Text]
Barbey, C., Baumgaertner, P., Devevre, E., Rubio-Godoy, V., Derre, L., Bricard, G., Guillaume, P., Luescher, I. F., Lienard, D., Cerottini, J.-C., Romero, P., Rufer, N., Speiser, D. E.
(2007). IL-12 Controls Cytotoxicity of a Novel Subset of Self-Antigen-Specific Human CD28+ Cytolytic T Cells. J. Immunol.
178: 3566-3574
[Abstract][Full Text]
Khandekar, J., Khandekar, M.
(2006). Phase 1 clinical trials: not just for safety anymore?. Arch Intern Med
166: 1440-1441
[Full Text]
Interview
