Healthy
Conditions
Keywords
Age-Related Macular Degeneration
Brief 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
Detailed description
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 \< 20/25 or Intraocular Pressure \> 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.
Interventions
DRUGEB-203
* Single dose : EB-203 1%, 2%, 4%, 8% 1Drop, QD / Day1. * Multiple dose : EB-203 1%, 2%, 4%, 8% 1Drop, BID / Day5\ Day8.
DRUGPlacebo
Placebo 1Drop, QD / Day1, BID / Day5\ Day8.
Sponsors
EyebioKorea, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction) | Single dose : up to 4 Days, Multiple dose : up to Day10, PSV | V/S, Physical Exam, ECG, Laboratory Exam, Ophthalmic Exam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Day1, Day2, Day8, Day9, Day10 | Cmax of EB-203 was derived across all post-dose PK collections and expressed in μg/mL. |
| Area under the plasma concentration versus time curve (AUC) | Day1, Day2, Day8, Day9, Day10 | 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). |
| Time to Maximum Serum Concentration (Tmax) | Day1, Day2, Day8, Day9, Day10 | Tmax of EB-203 was based on the Cmax derived across all post-dose PK collections and expressed in hours. |
| Terminal Elimination Half-Life (T1/2) | Day8. | T1/2 of EB-2-3 was derived across all PK collections and expressed in hours. |
Countries
South Korea
Outcome results
None listed