After the London tragedy, is it still possible to consider Phase I is safe?

摘要

The recent London tragedy induces a huge emotion in the clinical pharmacology world. As decided by the Medicines and Healthcare products Regulatory Agency, the main point is to redefine the acceptable conditions for fully humanized agonist monoclonal antibodies in man. Such anxiety could also be reinforced by the fact that three deaths in healthy subjects have recently been reported in the USA [2-4].