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).