KCT0008881已完成Unknown
Randomized, double-blind, placebo-controlled, dose-escalation, phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetic properties of EB-203 eye drops in healthy adult volunteers
Eyebiokorea0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •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
排除标准
- •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
- •1) Suspected symptoms or signs of visual organ disease including corneitis, uveitis, retinitis, dry eyes, and strabismus
- •2) Corrected visual acuity < 20/25 or Intraocular Pressure > 21 mmHg
- •3) Patients who have received any eye surgery
- •4) Other abnormal findings in ophthalmic examinations
- •3. Other patients considered by investigators to be inappropriate as subjects.
研究者
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