safety, tolerability and pharmacokinetics of eb-203 eye drops in healthy volunteers

Conditions: Healthy

Summary: the purpose of study is to evaluate safety, tolerability and pharmacokinetics of eb-203 drops in adult healthy volunteers. condition/disease : amd(age-related macular degeneration) intervention/treatment : eb-203 or placebo phase : phase i

study title : a phase i clinical trial to evaluate safety, tolerability and pharmacokinetics of eb-203 eye drops in healthy volunteers purpose : the purpose of study is to evaluate safety, tolerability and pharmacokinetics of eb-203 drops in adult healthy volunteers number of site : one site (inje university busan paik hospital) a total of 8 subjects will be dosed in each group(group b, c, d) with subjects randomized 3:1 to eb-203 or placebo.(a total of 4 subjucts will be dosed in group a) up to 28 subjects will be enrolled in four consecutive cohorts. a safety data review as masking will be performed for 4days prior repeated treatment. treatment of high dose will proceed following a review of safety data from low dose. safety and tolerability assessments and drug plasma concentrations will be evaluated throughout the study in all cohorts. outcome measures : 1. primary outcome measures : frequency of aes (adverse events) and adr (adverse drug reaction) 2. secondary outcome measures : pharmacokinetic variables evaluation for single and repeated dose administration. safety assessment : * v/s, physical exam, laboratory exam, ecg * ophthalmic exam investigational product(ip) : * active comparator : 1 %, 2 %, 4 %, 8% of eb-203 * placebo comparator : placebo intervention\&number of subject : total 28 subjects (a group 4, b\~d group 8) 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 : 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 * suspected symptoms or signs of visual organ disease including corneitis, uveitis, retinitis, dry eyes, and strabismus * corrected visual acuity \ 21 mmhg * patients who have received any eye surgery * other abnormal findings in ophthalmic examinations 3. other patients considered by investigators to be inappropriate as subjects.

Eligibility criteria:
inclusion criteria: * healthy adult males between the ages of 20 and 55 years * body weight \> 55 kg and bmi 18 \~ 27 kg/m2 * patients signed informed consent willing and able to sign informed consent form and comply with visit and study procedures per protocol exclusion criteria: * a person who has a history or presence of clinical significant cardiovascular, respiratory, hepatobiliary, renal/urinary, hematological, gastrointestinal, endocrine, neurological, psychiatric disease * a person who has the following diseases from medical and ophthalmic examination * suspected symptoms or signs of visual organ disease including corneitis, uveitis, retinitis, dry eyes, and strabismus * corrected visual acuity \ 21 mmhg * patients who have received any eye surgery * other abnormal findings in ophthalmic examinations * other patients considered by investigators to be inappropriate as subjects.

Keywords: age-related macular degeneration