Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 77
- 试验地点
- 3
- 主要终点
- Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of AGN-232411 topical ophthalmic solution in healthy participants and participants with dry eye.
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
- 18 Years 至 —（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
- 未提供
研究组 & 干预措施
Cohort 1A: AGN-232411 Dose A
One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants.
干预措施: AGN-232411 (Drug)
Cohort 1B: AGN-232411 Dose B
One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose A in Cohort 1A is acceptable.
干预措施: AGN-232411 (Drug)
Cohort 1C: AGN-232411 Dose C
One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose B in Cohort 1B is acceptable.
干预措施: AGN-232411 (Drug)
Cohort 1: AGN-232411 Vehicle
One drop of Vehicle for AGN-232411 topical ophthalmic solution administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants.
干预措施: AGN-232411 Vehicle (Drug)
Cohort 2A: AGN-232411 Dose A
One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease.
干预措施: AGN-232411 (Drug)
Cohort 2B: AGN-232411 Dose B
One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose A in Cohort 2A is acceptable.
干预措施: AGN-232411 (Drug)
Cohort 2C: AGN-232411 Dose C
One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose B in Cohort 2B is acceptable.
干预措施: AGN-232411 (Drug)
Cohort 2: AGN-232411 Vehicle
One drop of Vehicle for AGN-232411 topical ophthalmic solution administered to the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease.
干预措施: AGN-232411 Vehicle (Drug)
结局指标
主要结局
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 56 days
次要结局
未报告次要终点