This study is a randomized, double-blind, placebo-controlled phase 1 clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of GLH8NDE after single and multiple ocular administrations in healthy Korean and Caucasian volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
5% GLH8NDE as eye drops
Placebo as eye drops
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Adverse events
To 18 days after first IP administration
Time frame: Between 1 day before first IP administration and 18 days
Vital signs in blood pressure
Whether out of normal range at Blood pressure (SBP, DBP)
Time frame: Each point at Screening(between 2 day and 28 day before IP administration), 1, 2, 4, 6, 8, 10, 11 days, and post-study visit(between 16 and 18 days)
Vital signs in pulse
Whether out of normal range at Pulse rate
Time frame: Each point at Screening(between 2 day and 28 day before IP administration), 1, 2, 4, 6, 8, 10, 11 days, and post-study visit(between 16 and 18 days)
Vital signs in temperature
Whether out of normal range in temperature at eardrum
Time frame: Each point at Screening(between 2 day and 28 day before IP administration), 1, 2, 4, 6, 8, 10, 11 days, and post-study visit(between 16 and 18 days)
Physical examinations in weight change
Weight change in kilograms
Time frame: Change trend of the each point among screening(between 2 day and 28 day before IP administration), 1, 2, 4, 6, 8, 10, 11 days, and post-study visit(between 16 and 18 days)
Clinical laboratories in blood sample
Whether abnormal blood chemistry
Time frame: Each point at day 1, 2, 4, 6, 8, 10, and 11
Clinical laboratories in blood sample
Whether positive at Type B hepatitis, Type C hepatitis, HIV, and Syphilis
Time frame: Each point at day 1, 2, 4, 6, 8, 10, and 11
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12-lead ECG in clinical significance
Whether out of normal range QRS complex
Time frame: Each point at Screening(between 2 day and 28 day before IP administration), 1, 4, 11 days, and post-study visit(between 16 and 18 days)
Ophthalmic symptom
To 18 days after first IP administration
Time frame: Each point at Day 1, 2, 4, 6, 8, 10, and 11
Ophthalmic examination
Tear break-up time examination
Time frame: Each point at Screening(between 2 day and 28 day before IP administration), 2, 11 days, and post-study visit(between 16 and 18 days)
AUClast in ng·h/mL
One day administration as GLH8NDE
Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
AUCinf in ng·h/mL
One day administration as GLH8NDE
Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
Cmax in ng/mL
One day administration as GLH8NDE
Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
Tmax in ng/mL
One day administration as GLH8NDE
Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
t1/2 in hour
One day administration as GLH8NDE
Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
AUCtau,ss in ng·h/mL
Mutiple dose administration as GLH8NDE
Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
Cmax in ng/mL
Mutiple dose administration as GLH8NDE
Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
Tmax in ng/mL
Mutiple dose administration as GLH8NDE
Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
t1/2 in hour
Mutiple dose administration as GLH8NDE
Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration
R(Accumulation index)
Accumulation in dex at mutiple dose administration as GLH8NDE
Time frame: Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration