A Phase I Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Test group
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
干预措施: EB-203 (Drug)
Placebo group
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
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction)
时间窗: Single dose : up to 4 Days, Multiple dose : up to Day10, PSV
V/S, Physical Exam, ECG, Laboratory Exam, Ophthalmic Exam
次要结局
- 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.)