NCT07132437已完成1 期
Phase I Clinical Study of Systemic Pharmacokinetics and Safety of ZKY001 Eye Drops for Multiple Administration in Patients With Corneal Epithelial Defect After Corneal Endothelial Transplantation
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年12月29日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Estimate pharmacokinetic parameters
研究概览
简要总结
One dose group of 0.004% was used.
详细描述
One dose group of 0.004% was used. The whole study includes two stages: pre-test and formal test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-70 (including threshold);
- •Body mass index between 19-26kg/m2 (including critical value), male weight ≥50kg, female weight ≥45kg;
- •Patients who have undergone Descemet's stripping endothelial keratoplasty（DSEK）, Descemet's stripping automated endothelial keratoplasty（DSAEK） or Descemet membrane endothelial keratoplasty（DMEK） and need to remove corneal epithelium during surgery (the diameter of the removed epithelium area ≥8mm);
- •Lacrimal secretion test (Schirmer test I) ≥10mm/5min during screening;
- •Limbus structure was normal under slit-lamp during screening period;
- •Voluntarily sign informed consent.
排除标准
- •Smoking more than 5 cigarettes per day on average;
- •suspected or indeed alcohol dependence with an average intake of more than 2 units of alcohol per day for 3 months or positive alcohol test;
- •those who have a history of drug abuse or have a positive urine test;
研究组 & 干预措施
0.004% ZKY001 eye drops
Experimental
Start taking the medicine from Day 1 and continue for 6 consecutive days.
干预措施: ZKY001 EYE DROPS (Drug)
结局指标
主要结局
Estimate pharmacokinetic parameters
时间窗: Day 6
Pharmacokinetic parameters（Clearance/Bioavailability（CL/F）） were estimated based on plasma concentration of ZKY001 after multiple dosing
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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