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

NCT05538949 | Completed Phase 1 DMC

• 1 other identifier: EB-203-101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Maximum Observed Serum Concentration (Cmax)

  Day1, Day2, Day8, Day9, Day10

• Area under the plasma concentration versus time curve (AUC)

  Day1, Day2, Day8, Day9, Day10

• Time to Maximum Serum Concentration (Tmax)

  Day1, Day2, Day8, Day9, Day10

• Terminal Elimination Half-Life (T1/2)

  Day8.

Study Arms (2)

Test group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

EB-203 DRUG

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

Test group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• EyebioKorea, Inc.: lead

Study Sites (1)

Busan Paik Hospital, Inje University

Busan, 47392, South Korea

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jong-Lyul Ghim

  Busan Paik Hospital, Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 14, 2022
• Study Start: June 29, 2022
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

KR (1)