Harmanjit Singh1, Sudhir Chandra Sarangi2, Yogendra Kumar Gupta2
1Department of Pharmacology, Government Medical College and Hospital, Chandigarh, India.
2Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.
DOI: 10.4103/jnsbm.JNSBM_181_17


Phase I clinical trial is the first exposure of investigational medicinal product in humans and it sets the pillar for further clinical development. Substantial attention has been paid to the first in human clinical trials after TeGenero TGN1412 disaster in 2006 which led to serious toxicity including multi-organ failure in 6 healthy volunteers. Since then many recommendation and guidelines have been formulated for the safe and rational conduct of such trials. In January 2016, another catastrophe occurred in France during Phase I trial of BIA 10-2474, a fatty acid amide hydrolase inhibitor, which led to one death and caused serious neurological damage in few other healthy volunteers. This review will focus on potential issues in BIA 10-2474 trial, possible measures that should have been taken during trials to prevent this disaster and potential safety measures for the rational and safe conduct of Phase I trials.

Keywords: BIA 10-2474, Phase I, Serious adverse event, TGN1412.

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