NCT04403763终止1 期
A First-in-Human, Phase 1/2, Dose-ascending, Multicenter, Masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AGN-241622 in Healthy Participants and Participants With Presbyopia (Stage 1 and Stage 2) and Efficacy in Participants With Presbyopia (Stage 2)
AbbVie10 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年7月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622
研究概览
简要总结
The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 65 at the time of study participation.
- •Be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year.
- •Be able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor.
排除标准
- •History of alcohol or substance abuse within the 5 years prior to study participation.
- •Enrollment in another investigational drug or device study within 30 days of study participation.
- •Women who are pregnant, nursing, or planning a pregnancy during the study.
研究组 & 干预措施
Placebo Dose
Placebo Comparator
Administered as single drop in one or both eyes
干预措施: Vehicle (Drug)
Cohort 1: AGN-241622 Dose 1 (Low Dose)
Experimental
Administered as single drop in one eye
干预措施: AGN-241622 (Drug)
Cohort 2: AGN-241622 Dose 2 (Medium Dose)
Experimental
Administered as single drop in one eye
干预措施: AGN-241622 (Drug)
Cohort 3: AGN-241622 Dose 3 (High Dose)
Experimental
Administered as single drop in one eye
干预措施: AGN-241622 (Drug)
Cohort 4: AGN-241622 Dose 1 (Low Dose)
Experimental
Administered as a single drop in each eye
干预措施: AGN-241622 (Drug)
Cohort 5: AGN-241622 Dose 2 (Medium Dose)
Experimental
Administered as single drop in each eye
干预措施: AGN-241622 (Drug)
Cohort 6: AGN-241622 Dose 3 (High Dose)
Experimental
Administered as single drop in each eye
干预措施: AGN-241622 (Drug)
结局指标
主要结局
Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622
时间窗: Up to 2 days
The number of participants who experience one or more TEAE during the treatment period
Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622
时间窗: 14 Days
The number of patients who experience one or more TEAE during the treatment period
次要结局
- Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622(Day 1)
- Stage 1 Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622(Day 1)
- Stage 1 Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622(Day 1)
- Stage 1 Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622(Day 1)
- Stage 1 Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622(Day 1)
- Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)(Day 1)
- Stage 1 Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622(Day 1)
- Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622(Day 1)
- Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622(Day 1)
- Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622(Day 1)
- Stage 1 Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622(Day 1)
- Stage 2a Plasma Pharmacokinetics: Minimum Plasma Concentrations (Cmin) of AGN-241622(14 Days)
- Stage 2a Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622(14 Days)
- Stage 2a Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)(14 Days)
- Stage 2a Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622(14 Days)
- Stage 2a Plasma Pharmacokinetics: Accumulation Ratio of AGN-241622(14 Days)
- Stage 2a Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622(14 Days)
- Stage 2a Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622(14 Days)
- Stage 2a Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622(14 Days)
- Stage 2a Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622(14 Days)
- Stage 1 Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622(Day 1)
- Stage 1 Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622(Day 1)
- Stage 1: Pupil Diameter Measurement(Day 1)
- Stage 1 Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622(Day 1)
- Stage 2a Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622(14 Days)
- Stage 2a Plasma Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622(14 Days)
- Stage 2a Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622(14 Days)
- Stage 2a Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622(14 Days)
- Stage 2a Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622(14 Days)
- Stage 2a Tears Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622(14 Days)
- Stage 2a Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622(14 Days)
研究者
研究点 (10)
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