Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
- Registration Number
- NCT05538949
- Lead Sponsor
- EyebioKorea, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
- 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
-
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo group Placebo 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 Test group EB-203 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Busan Paik Hospital, Inje University
🇰🇷Busan, Korea, Republic of