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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: EB-203; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 47392
    • Busan Paik Hospital, Inje University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: EyebioKorea, Inc.
• Investigators: Principal Investigator: Jong-Lyul Ghim, Busan Paik Hospital, Inje University

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): October 7, 2022

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: September 11, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Age-Related Macular Degeneration
• Other Study ID Numbers: EB-203-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No