Treatment
PD, PK/PD
ADVERSE EVENTS
The study included a screening period (week 4 to week 1), a safety monitoring period (4 weeks for Group A1, and 3 weeks for Groups A2-A5), and a safety follow-up period (up to week 24) (Schematic presentation of the study. W, week; SAD, single ascending dose; PK, pharmacokinetic; PD, pharmacodynamics.After review (including but not limited to reported adverse events [AEs], vital signs, electrocardiogram [ECG], and clinical laboratory test results) and evaluation of safety data with reference to the available PK/PD data by the Independent Safety Review Committee (iSRC), it was decided to conduct a further dose escalation and safety monitoring period. All study personnel remained blinded to treatment until study completion.