Severe adverse reactions prompt call for trial design changes

doi:10.1136/bmj.332.7543.683

BMJ 2006;332:683 (25 March), doi:10.1136/bmj.332.7543.683

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Severe adverse reactions prompt call for trial design changes

Susan Mayor

London

The first 150 words of the full text of this article appear below.

Drugs from new chemical or biological classes being tested inphase I trials—the earliest trials of a new drug in humans—shouldbe tested in only one person at a time, a specialist said aftera UK phase I trial resulted in six healthy volunteers becomingseverely ill.

The young men were taking part in the first study in humansof TGN1412, a fully humanised monoclonal antibody designed tobind to CD28, a cell surface molecule on T cells which playa role in a variety of cell mediated immune reactions. The drugwas being developed for the treatment of autoimmune and inflammatorydiseases and leukaemia by a German company, TeGenero.

The six volunteers developed severe reactions within three hoursof being given TGN1412 intravenously, while two other men whowere given a placebo showed no sign of illness. One of thosewho was given the placebo told the BBC that . . . [Full text of this article]

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