Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): EB-203; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose : EB-203 1%, 2%, 4%, 8% 1Drop, QD / Day1.
Multiple dose : EB-203 1%, 2%, 4%, 8% 1Drop, BID / Day5~Day8.; Placebo 1Drop, QD / Day1, BID / Day5~Day8.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Age-Related Macular Degeneration