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

News

Severe adverse reactions prompt call for trial design changes

London

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

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

The young men were taking part in the first study in humans of TGN1412, a fully humanised monoclonal antibody designed to bind to CD28, a cell surface molecule on T cells which play a role in a variety of cell mediated immune reactions. The drug was being developed for the treatment of autoimmune and inflammatory diseases and leukaemia by a German company, TeGenero.

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

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