Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers

Study Overview
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Brief Summary
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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

Detailed Description
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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 : Primary Outcome Measures : Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction) 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 : 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 < 20/25 or Intraocular Pressure > 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.

Official Title
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A Phase I Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: EB-203
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 < 20/25 or Intraocular Pressure > 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Participants received 1%, 2%, 4%, 8% of EB-203 eye drops. Group A : EB-203 1% eye drops, Group B : EB-203 2% eye drops, Group C : EB-203 4% eye drops, Group D : EB-203 8% eye drops | Drug: EB-203<br>* Single dose : EB-203 1%, 2%, 4%, 8% 1Drop, QD / Day1. Multiple dose : EB-203 1%, 2%, 4%, 8% 1Drop, BID / Day5 Day8.<br>|
| Placebo Comparator: Placebo group<br>Participants received Placebo eye drops. Group A : Placebo eye drops, Group B : Placebo eye drops, Group C : Placebo eye drops, Group D : Placebo eye drops | Drug: Placebo<br>* Placebo 1Drop, QD / Day1, BID / Day5 Day8.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction) | V/S, Physical Exam, ECG, Laboratory Exam, Ophthalmic Exam | Single dose : up to 4 Days, Multiple dose : up to Day10, PSV | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Serum Concentration (Cmax) | Cmax of EB-203 was derived across all post-dose PK collections and expressed in μg/mL. | Day1, Day2, Day8, Day9, Day10 | 
| Area under the plasma concentration versus time curve (AUC) | AUC of EB-203 in serum over the time interval from 0 extrapolated to infinity. Values for AUC of EB-203 were expressed in days by micrograms per milliliter (days•μg/mL). | Day1, Day2, Day8, Day9, Day10 | 
| Time to Maximum Serum Concentration (Tmax) | Tmax of EB-203 was based on the Cmax derived across all post-dose PK collections and expressed in hours. | Day1, Day2, Day8, Day9, Day10 | 
| Terminal Elimination Half-Life (T1/2) | T1/2 of EB-2-3 was derived across all PK collections and expressed in hours. | Day8. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-Related Macular Degeneration