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Starting Dose Selection in First-in-Human Trials
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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.