Clinical trial NCT05538949: Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
Official title: A Phase I Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Age-Related Macular Degeneration
Lead sponsor: EyebioKorea, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction)
timeFrame: Single dose : up to 4 Days, Multiple dose : up to Day10, PSV
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Day1, Day2, Day8, Day9, Day10
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Day1, Day2, Day8, Day9, Day10
measure: Time to Maximum Serum Concentration (Tmax)
timeFrame: Day1, Day2, Day8, Day9, Day10
measure: Terminal Elimination Half-Life (T1/2)
timeFrame: Day8.
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital, Inje University
Study officials:
affiliation: Busan Paik Hospital, Inje University
name: Jong-Lyul Ghim
role: PRINCIPAL_INVESTIGATOR
References: