Clinical trial: A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers (NCT04104997)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? 1