Study design and subjects
This study was a phase 1, randomized, double-blind, placebo-controlled, and single ascending dose (SAD) and multiple ascending dose (MAD) study. The subjects were enrolled and randomly assigned to the rhEGF eyedrops (10, 50, or 100 μg/mL) or placebo in a 3:1 ratio. The subjects received rhEGF or placebo twice a day for one day and 14 days in the SAD and the MAD study, respectively. The subjects who were assigned to the rhEGF eyedrops received rhEGF eyedrop in one eye which was randomly assigned and placebo in the other eye. Dose escalation was determeind based on the evaluation of safety/tolerability data from the previous dose groups. In addition, whether to proceed to the MAD study was determined based on the safety/tolerability results of the SAD study.
In this study, healthy male subjects who had bodyweight of 50-100 kg and body mass index more than 18.0 kg/m2 with 19-50 years of age were eligible for enrollment into the study if no clinically significant abnormalities were observed in medical history, physical and ophthalmic examinations, clinical laboratory tests, vital signs, and 12-lead electrocardiograms (ECG).