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

NCT ID: NCT05538949

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-29
• Study Completion Date: 2022-10-07

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

EB-203

Intervention Type: DRUG

• Single dose : EB-203 1%, 2%, 4%, 8% 1Drop, QD / Day1.
• Multiple dose : EB-203 1%, 2%, 4%, 8% 1Drop, BID / Day5~Day8.

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 1Drop, QD / Day1, BID / Day5\~Day8.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo 1Drop, QD / Day1, BID / Day5\~Day8.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

EyebioKorea, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jong-Lyul Ghim

Role: PRINCIPAL_INVESTIGATOR

Busan Paik Hospital, Inje University

Locations

Busan Paik Hospital, Inje University

Busan, , South Korea

Countries

South Korea

Other Identifiers

EB-203-101

Identifier Type: -

Identifier Source: org_study_id