Establishing risk of human experimentation with drugs: lessons from TGN1412

Particular care is necessary when a new drug is given to healthy volunteers without previous human testing. General principles for such research have been laid down in guidelines as early as 1983, and these were the basis for many current regulations. 2 Most drugs at that time were small molecules with fairly well characterised, classic, pharmacological mechanisms. Proposed primary objectives for studies in healthy people were therefore to show pharmacological action in man and the dose (or concentration) response curve. This approach was judged safe and was lent support by fi ndings of available surveys. 3,4