Demographic Characteristics of Subjects in the Three Parts of the Phase-I Study on Flubentylosin.
MAD: multiple ascending dose; SAD: single ascending dose; SD: standard deviationThe 12 subjects enrolled in Part 2 (food effect) were discontinued from the study after completing Period 1 because two subjects in Period 1 experienced AEs of elevated liver enzymes that were considered possibly related to the study drug, which met a prespecified pause criterion. As a result, Period 2 of Part 2 of the study was put on hold. The flubentylosin development team hypothesized that the liver enzyme elevations were related to flubentylosin C