A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects
详细描述
Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 51 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male aged from 20 to 51 at screening test
- •Weight 50kg ~100kg BMI 18-27
- •Those who are fully understood, voluntarily decided to participate and signed prior to screening
- •Those who are deemed suitable for participating in clinical trial due to lab tests, physical exam etc
排除标准
- •Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)
研究组 & 干预措施
Group A rhEGF 10mcg/mL
single dose of rhEGF 10mcg/mL eye drop or single dose of placebo
*single dose means daily dose (administration twice daily)
干预措施: Single dose of rhEGF 10mcg/ml or placebo (Drug)
Group B rhEGF 50mcg/mL
single dose of rhEGF 50mcg/mL eye drop or single dose of placebo
*single dose means daily dose (administration twice daily)
干预措施: Single dose of rhEGF 50mcg/ml or placebo (Drug)
Group C rhEGF 100mcg/mL
single dose of rhEGF 100mcg/mL eye drop or single dose of placebo
*single dose means daily dose (administration twice daily)
干预措施: Single dose of rhEGF 100mcg/ml or placebo (Drug)
Group D rhEGF 10mcg/mL
multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo
干预措施: Multiple dose of rhEGF 10mcg/ml or placebo (Drug)
Group E rhEGF 50mcg/mL
multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo
干预措施: Multiple dose of rhEGF 50mcg/ml or placebo (Drug)
Group F rhEGF 100mcg/mL
multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo
干预措施: Multiple dose of rhEGF 100mcg/ml or placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: 14 days from baseline
* sign and symptoms of AE * physical exam, vital signs, ECG exam, lab test * ophthalmic exam: schirmer's test, TBUT test, slit lamp exam etc * Immunogenicity test (anti-drug antibody)
次要结局
- PK characteristics(14 days from baseline)