Safety, Tolerability and Pharmacokinetic Profile of Different Doses of SYL1801 Ophthalmic Solution in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (1 day of treatment).
研究概览
简要总结
Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Body mass index (BMI) between 19.5 and 29.0 kg/m2
- •Intraocular pressure (IOP) <=21 mmHg
- •Best Corrected Visual Acuity (BCVA) >= 70 ETDRS
- •Normal corneal and conjunctival assessment
- •Normal funduscopy
排除标准
- •Pregnant or breastfeeding females or those with a positive pregnancy test. Females of childbearing potential who will not use a medically acceptable contraceptive method
- •Current relevant diseases according to the investigator's judgement.
- •Previous relevant chronic processes according to the investigator's judgement
- •Relevant visual alterations according to the investigator's judgement
- •Administration of systemic medications
- •Case history of hypersensitivity to medicinal products or any other allergic process
- •Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.
研究组 & 干预措施
Multiple administrations High Dose once daily
7 treatment days
干预措施: SYL18001 sodium High dose q.d (Drug)
Single administration Low Dose once daily
1 treatment day
干预措施: SYL18001 sodium Low dose q.d (Drug)
Single administration Middle Dose once daily
1 treatment day
干预措施: SYL18001 sodium Middle dose q.d (Drug)
Single administration High Dose once daily
1 treatment day
干预措施: SYL18001 sodium High dose q.d (Drug)
Single administration High Dose twice daily
1 treatment day
干预措施: SYL18001 sodium High dose b.i.d (Drug)
Multiple administrations Low Dose once daily
7 treatment days
干预措施: SYL18001 sodium Low dose q.d (Drug)
Multiple administrations Middle Dose once daily
7 treatment days
干预措施: SYL18001 sodium Middle dose q.d (Drug)
Multiple administrations High Dose twice daily
7 treatment days
干预措施: SYL18001 sodium High dose b.i.d (Drug)
结局指标
主要结局
Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (1 day of treatment).
时间窗: 72 hours after last instillation
Slit lamp evaluation
Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (7 days of treatment).
时间窗: 72 hours after last instillation
Slit lamp evaluation
Determination of the maximum Plasma Concentration [Cmax]
时间窗: - 15 - 30 minutes, 1- 4 and 24 hours after last administration
Determination of the Area Under the Curve of plasma concentrations until the last extraction time [AUT 0-t]
时间窗: - 15 - 30 minutes, 1- 4 and 24 hours after last administration
次要结局
未报告次要终点