Following the life-threatening adverse event that occurred after the FIH administration of a CD28 super-agonist antibody, early testing in humans was revisited by a UK scientific expert. Based on the resulting "Duff Report", the European Medicines Agency (EMEA) drafted new guidance underlining the need to better mitigate the risk when first-in-human dosing is concerned. This paper aims at presenting diverse strategies supporting the choice of the starting dose that were seen in recent FIH trials conducted at the SGS Clinical Pharmacology Units.
Access to all documents and request for further information are available to all users at no cost. In order to provide you with this free service, William Reed Business Media SAS does share your information with companies that have content on this site. When you access a document or request further information from this site, your information may be shared with the owners of that document or information.