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

EyebioKorea

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: EB-203; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05538949

EB-203-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

Test group

Experimental group

Description:

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

Treatment:

Drug: EB-203

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo