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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05538949
• Other study ID #: EB-203-101
• Status: Completed
• Phase: Phase 1
• Start date: June 29, 2022
• Est. completion date: October 7, 2022

Study information

• Verified date: February 2023
• Source: EyebioKorea, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Busan Paik Hospital, Inje University	Busan

Sponsors (1)

Lead Sponsor	Collaborator
EyebioKorea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Terminal Elimination Half-Life (T1/2)	T1/2 of EB-2-3 was derived across all PK collections and expressed in hours.	Day8.