None listed
Conditions
Interventions
Drug : In this phase I, double-blinded, placebo-controlled trial, 28 healthy volunteers were randomized to four treatment arms: 1, 2, 4, and 4*2% novel peptide (3, 6, 6, and 6 subjects, respectively)
ocular and systemic safety and tolerability assessments were conducted throughout the study.
Sponsors
Eyebiokorea
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy adult males between the ages of 20 and 55 years 2. Body Weight > 55 kg and BMI 18 ~ 27 kg/m2 3. Patients signed informed consent willing and able to sign informed consent form and comply with visit and study procedures per protocol
Exclusion criteria
Exclusion criteria: 1. A person who has a history or presence of clinical significant Cardiovascular, Respiratory, Hepatobiliary, Renal/Urinary, Hematological, Gastrointestinal, Endocrine, Neurological, Psychiatric disease 2. A person who has the following diseases from medical and ophthalmic examination 1) Suspected symptoms or signs of visual organ disease including corneitis, uveitis, retinitis, dry eyes, and strabismus 2) Corrected visual acuity 21 mmHg 3) Patients who have received any eye surgery 4) Other abnormal findings in ophthalmic examinations 3. Other patients considered by investigators to be inappropriate as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event and Adverse Drug Reaction collected from History taking, Review of systems, Physical examination, Vital sign, ECG, Clinical laboratory test, Ophthalmological examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Variable((AUC, Cmax, Tmax, t1/2 et al) | — |
Countries
Korea, Republic of
Contacts
Public ContactJong-Lyul Ghim
Inje University Busan Paik Hospital
Outcome results
None listed