2.5 Safety Assessments
Safety was assessed by monitoring adverse events (AEs) throughout the
studies. Other safety monitoring included 12‐lead ECG recordings,
measurement of vital signs, physical and neurological examinations,
haematology, biochemistry and urinalysis. To minimise risks in the SAD
and multiple ascending dose (MAD) studies, subjects were dosed
sequentially using sentinels in each cohort (1 IP, 1 placebo) as per EMA
guidelines.14 If the previous dose was well tolerated,
with no safety concerns, dose escalation was decided by the Safety
Review Group after reviewing safety and PK data from all available
cohorts. Moreover, treatment with the highest dose in the SAD study was
repeated for regular ophthalmological evaluations to better characterise
AEs observed in the SAD study. Regular ophthalmological assessments were
also performed in the MAD study.