A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 51
- 主要终点
- Maximal Plasma Concentration (Cmax) of AGN-223575
研究概览
简要总结
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weight at least 110 lbs
排除标准
- •Use of contact lenses within 14 days, or planned use during the study
- •Use of any ocular eye medications within 30 days, or anticipated use during the study
- •Anticipated use of any artificial tears product during the study
研究组 & 干预措施
Cohort 1: AGN-223575 Form A/Vehicle
One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
干预措施: AGN-223575 Formulation A (Drug)
Cohort 1: AGN-223575 Form A/Vehicle
One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
干预措施: AGN-223575 Vehicle (Drug)
Cohort 2: AGN-223575 Formulation A BID
One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
干预措施: AGN-223575 Formulation A (Drug)
Cohort 3: AGN-223575 Formulation B BID
One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
干预措施: AGN-223575 Formulation B (Drug)
Cohort 4: AGN-223575 Formulation C BID
One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
干预措施: AGN-223575 Formulation C (Drug)
AGN-223575 Vehicle BID
One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
干预措施: AGN-223575 Vehicle (Drug)
Cohort 5: AGN-223575 Formulation C TID
One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
干预措施: AGN-223575 Formulation C (Drug)
AGN-223575 Vehicle TID
One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
干预措施: AGN-223575 Vehicle (Drug)
结局指标
主要结局
Maximal Plasma Concentration (Cmax) of AGN-223575
时间窗: Day 15
Concentrations of AGN-223575 were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 24 hours post-dose. The Cmax is reported.
次要结局
未报告次要终点