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.