A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects With Presbyopia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- T1/2
研究概览
简要总结
Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia
详细描述
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Have known contraindications or sensitivity to the use of any of the investigational products or its components, or any other medications required by the protocol.
- •Have any active systemic or ocular disorder that has a potential risk to or impact on subject safety, study process or study results other than refractive disorder.
- •Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the investigator's opinion could affect ophthalmic solution absorption in either eye.
- •Have prior (within 14 days of the first dose), current or anticipated use of any contact lenses during study participation.
- •Be ineligible for this trial in the opinion of the investigator.
研究组 & 干预措施
LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Drug: Aceclidine/Brimonidine ophthalmic solution Other Names: LNZ101
干预措施: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution (Drug)
LNZ100 (Aceclidine) ophthalmic solution
Drug: Aceclidine ophthalmic solution Other Names: LNZ100
干预措施: LNZ100 (Aceclidine) ophthalmic solution (Drug)
Placebo (Vehicle) ophthalmic solution
Drug: Placebo (Vehicle) ophthalmic solution Other Names: NA
干预措施: Placebo (Vehicle) ophthalmic solution (Drug)
结局指标
主要结局
T1/2
时间窗: Day 1 and Day 8
Terminal half-life of LNZ100 and LNZ101
Cmax
时间窗: Day 1 and Day 8
Maximum plasma concentrations of LNZ100 and LNZ101
Tmax
时间窗: Day 1 and Day 8
Time of maximum plasma concentrations of LNZ100 and LNZ101
AUC0-t
时间窗: Day 1 and Day 8
Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100
AUC0-∞
时间窗: Day 1 and Day 8
Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101
Safety: adverse event reporting
时间窗: up to 23 days
The number of patients who experience one or more AE during the treatment period
次要结局
未报告次要终点