Safety
pneumonia, pain, SAD
PNEUMONIA, UPPER RESPIRATORY INFECTIONS, ADVERSE EVENTS, ADVERSE EVENT, EVENTS
A total of 56 subjects were enrolled in the study (Table Demographics of subjects.In the SAD part, there were a total of 10 TEAEs reported by 9 subjects (22.5%). The majority of subjects reported mild events, considered unrelated to OCS-05 (Table Overall summary of TEAEs – SAD part.During the MAD part, a total of 9 TEAEs were reported by 5 (31.3%) subjects. The majority of subjects reported mild events, considered unrelated to treatment. No significant differences between TEAEs were observed between different OCS-05 doses. Review of the summary statistics revealed little difference between OCS-05 and placebo in the means and mean changes from baseline in 12-lead ECG parameters with similar values observed for placebo, 2.4 mg and 3.0 mg OCS-05. No subjects had 12-lead ECG data that met study stopping criteria. There was 1 serious adverse event (severe pneumonia; unlikely to be related to study medication) following placebo (Table Overall summary of TEAEs–MAD part.Overall, the most common adverse events were pain and upper respiratory infections. No other ECG abnormalities outside the one reported above were detected. Indeed, no abnormalities were observed in blood tests, EEG, or brain MRI.