Dry Eye Syndromes
Conditions
Brief summary
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
Interventions
DRUG5% GLH8NDE
5% GLH8NDE as eye drops
DRUGPlacebos
Placebo as eye drops
Sponsors
GL Pharm Tech Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subject who, at the time of screening, are the age between 20 and 50 years * Subject who has body weight between 55.0 and 90.0 kg, and BMI between 18.0 and 27.0 * Subject who signed and dated the informed consent form after understanding fully to hear a detailed explanation in the clinical trial
Exclusion criteria
* A subject who has a evidence or history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, urological, psychiatric, cardiovascular, hematological, oncological, etc. * A subject who has a history of disease with myocardial infarction, stroke, arrhythmia, hypotension (90 mmHg amine or diastolic blood pressure less than 50 mmHg at screening), uncontrolled hypertension (greater than 170 mmHg diastolic blood pressure or 100 mmHg diastolic blood pressure at screening), coronary artery, or who has a current abnormality * A subject with a history of hypersensitivity to the drug (aspirin, antibiotics, etc.) or clinical significant hypersensitivity reactions * A subject with the following findings in paperweight, visual acuity test, front eye photo, corneal refraction test, intraocular pressure test, slit lamp microscopy examination, fundus examination, tear break-up time examination, tear secretion test, OSDI (ocular surface disease index) are excluded 1. A subject with suspected history or symptoms of visual organs, including keratitis, uveitis, retinitis, dry eye and strabismus 2. A subject who has had eye surgery (including those who have received more than 6 months for eye laser surgery) 3. A subject at least one eye with an intra-ocular pressure of 22 mmHg or more at the screening 4. At the screening, tear break-up time of at least one eye in both eyes is less than 10 seconds and diagnosed as dry eye according to OSDI test 5. A subject whose ratio for at least one eye in both eyes during screening is less than 10 mm as measured for 5 minutes in an Un-anesthetized Schirmer's test 6. There are side effects to people who wear contact lenses after wearing them or within a month * A subject with a history of drug abuse or a positive urine drug screening for drug abuse * A subject who has participated in any other clinical trials and bioequivalence had medication within 6 months prior to the first administration of investigational product (The end date of another clinical trial is based on the last day of the administration) * A subject who has taken any ethical-the-counter drug or herbal drug within 2 weeks has taken any over-the-counter drug or vitamin include artificial tears within 1 week before the investigational product * A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration * History of regular alcohol consumption exceeding 21 units/week (1 unit = 10 g of pure alcohol) within 60 days before the investigational product or non-stop the alcohol drinking * The current smoker, but except the subject to quit the smoke over 90 days * Recognized contraceptive methods (e.g. your and your partner's infertility surgery, your partner's intrauterine device (IUD), cervical caps or contraceptive diaphragms for use with spermicides) Single block), cervical cap or contraceptive diaphragm with male condom (double block)\] * A subject who have to work that cause excessive eye fatigue during this clinical trial * A subject who is not eligible for the study due to reasons on the investigators' judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax in ng/mL | Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration | One day administration as GLH8NDE |
| Adverse events | Between 1 day before first IP administration and 18 days | To 18 days after first IP administration |
| Vital signs in blood pressure | 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) | Whether out of normal range at Blood pressure (SBP, DBP) |
| Vital signs in pulse | 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) | Whether out of normal range at Pulse rate |
| Vital signs in temperature | 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) | Whether out of normal range in temperature at eardrum |
| Physical examinations in weight change | 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) | Weight change in kilograms |
| Clinical laboratories in blood sample | Each point at day 1, 2, 4, 6, 8, 10, and 11 | Whether abnormal blood chemistry |
| 12-lead ECG in clinical significance | 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) | Whether out of normal range QRS complex |
| Ophthalmic symptom | Each point at Day 1, 2, 4, 6, 8, 10, and 11 | To 18 days after first IP administration |
| Ophthalmic examination | 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) | Tear break-up time examination |
| AUClast in ng·h/mL | Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration | One day administration as GLH8NDE |
| AUCinf in ng·h/mL | Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration | One day administration as GLH8NDE |
| Tmax in ng/mL | Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration | One day administration as GLH8NDE |
| t1/2 in hour | Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration | One day administration as GLH8NDE |
| AUCtau,ss in ng·h/mL | Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration | Mutiple dose administration as GLH8NDE |
| R(Accumulation index) | Pre-dose, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours after last administration | Accumulation in dex at mutiple dose administration as GLH8NDE |
Countries
South Korea
Outcome results
None listed