Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 :
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test group 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
Single dose : EB-203 1%, 2%, 4%, 8% 1Drop, QD / Day1.
Multiple dose : EB-203 1%, 2%, 4%, 8% 1Drop, BID / Day5~Day8.
|
| Placebo Comparator: Placebo group 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
Placebo 1Drop, QD / Day1, BID / Day5~Day8.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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 < 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Busan Paik Hospital, Inje University | Busan | Korea, Republic of | 47392 |
Sponsors and Collaborators
- EyebioKorea, Inc.
Investigators
- Principal Investigator: Jong-Lyul Ghim, Busan Paik Hospital, Inje University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EB-203-101