NCT01714960已完成1 期
Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
- To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2).
- To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For stage 1:
- •Healthy volunteers
- •For stage 2:
- •Glaucoma patients
排除标准
- •For stage 2:
- •Any relevant eye disease other than glaucoma
研究组 & 干预措施
Healthy volunteers low dose
Experimental
MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.
干预措施: MRZ-99030 eye drops 5mg/mL (Drug)
Healthy volunteers high dose
Experimental
MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.
干预措施: MRZ-99030 eye drops 20mg/mL (Drug)
Glaucoma patients
Experimental
MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.
干预措施: MRZ-99030 eye drops 20mg/mL (Drug)
Placebo
Placebo Comparator
Placebo eye drops, 1-3 drops three times per day, duration: 16 days.
干预措施: Placebo to MRZ-99030 eye drops (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Day 1 up to day 23
次要结局
- Maximal plasma concentration (Cmax)(Day 1 to day 17)
- Area under the curve (AUC)(Day 1 to day 17)
研究者
研究点 (1)
Loading locations...
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