NCT05538949

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: EyebioKorea, Inc. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
DRUG	Placebo	Placebo 1Drop, QD / Day1, BID / Day5\~Day8.

Timeline

• Start date: 2022-06-29
• Primary completion: 2022-10-07
• Completion: 2022-10-07
• First posted: 2022-09-14
• Last updated: 2023-02-23

Locations

1 site across 1 country: South Korea