A Mechanistic Model of Drug-Induced Liver Injury Aids the Interpretation of Elevated Liver Transaminase Levels in a Phase I Clinical Trial

Abstract

Entolimod (CBLB502) is a Toll-like receptor 5 agonist in development as a single-dose countermeasure against total body irradiation. Efficacy can be assessed from animal studies, but the "Animal Rule" does not apply to safety assessment. Marked elevations of serum aminotransferases (exceeding 1,000 IU/l) were observed in some human subjects receiving… (More)
DOI: 10.1038/psp.2013.74

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