Safety results
Sixteen subjects reported a total of 26 treatment-emergent adverse
events (TEAEs). Among the 22 subjects who received placebo, 6 (27%)
reported a total of 10 TEAEs; 9 were considered drug-related. Among the
21 subjects who received zamicastat, 12 (57%) reported a total of 16
TEAEs; of these, 13 were considered related to the treatment. The most
common drug-related TEAE was “orthostatic hypotension” of mild
intensity, which was reported by 4 (18%) subjects with placebo and 5
(24%) subjects with zamicastat. One TEAE (“acute cardiac event”),
which occurred with placebo, was considered of severe intensity. It was
considered a serious adverse event (SAE) due to hospitalization, leding
to subject withdrawal from the study. All remaining TEAEs were of mild
intensity. No deaths, further SAEs, or discontinuations due to TEAEs
were registered, and no clinically relevant change or clinically
significant abnormality in vital signs, physical examinations, and
clinical laboratory tests were observed. Vital signs and ECG parameters
did not show any overall trend.