Safety, Tolerability and Pharmacokinetics of Single Rising Intravitreal Doses and Multiple Intravitreal Dosing of BI 754132 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (Open Label, Non-randomized, Uncontrolled).
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 13
- 主要终点
- SRD Part: Number of Patients With Ocular (in the Study Eye) or Systemic Dose Limiting Events (DLEs)
研究概览
简要总结
This is a study in adults with geographic atrophy, an advanced form of age-related macular degeneration. The purpose of this study is to find out how well different doses of BI 754132 are tolerated.
The participants are in the study for about 4 months. During this time, they visit the study site about 10 times. Participants receive 1 injection of BI 754132 directly into one of the eyes affected by geographic atrophy. In this study, BI 754132 is given to humans for the first time.
The doctors compare how well participants tolerate the different doses of BI 754132. The doctors also regularly check the general health of the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
0.3 mg BI 754132 - SRD part
0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.
干预措施: BI 754132 (Drug)
1 mg BI 754132 - SRD part
1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
干预措施: BI 754132 (Drug)
3 mg BI 754132 - SRD part
3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
干预措施: BI 754132 (Drug)
6 mg BI 754132 - SRD part
6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
干预措施: BI 754132 (Drug)
6 mg BI 754132 - MD part
6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as 3 injections, each separated by 4 weeks (that is, Day 1, Day 29 and Day 57). Multiple dose.
干预措施: BI 754132 (Drug)
结局指标
主要结局
SRD Part: Number of Patients With Ocular (in the Study Eye) or Systemic Dose Limiting Events (DLEs)
时间窗: From drug administration until end of trial, up to 100 days.
SRD part: Number of patients with ocular or systemic DLEs from drug administration. Systemic DLEs were defined as drug-related adverse events (AEs), as defined by the investigator, of moderate or severe intensity on the Common terminology criteria for adverse events (CTCAE) scale, and included diarrhea, cough, or patient-reported paraesthesia, dysgeusia, taste abnormality, taste disorder, or hyposmia. Single rising dose (SRD) part.
MD Part: Number of Patients With Drug Related Adverse Events (AEs)
时间窗: From drug administration until end of trial, up to 155 days
Number of patients with drug-related adverse events (AEs). Multiple dose (MD) part.
次要结局
- SRD Part: Maximum Serum Concentration of BI 754132 After a Single Intravitreal Dose (Cmax)(At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.)
- MD Part: Trough Levels of BI 754132 Before Third Administration (Cmin,2)(Up to 57 days.)
- SRD Part: Number of Patients With Drug-related Adverse Events (AEs)(From drug administration until end of trial, up to 100 days.)
- SRD Part: Number of Patients With Any Ocular Adverse Events (AEs) in the Study Eye(From drug administration until end of trial, up to 100 days.)
- SRD Part: Area Under the Concentration-time Curve of BI 754132 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.)
- SRD Part: Time From Dosing to Maximum Serum Concentration of BI 754132 (Tmax)(At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.)
- MD Part: Plasma Concentration of BI 754132 4, 8 and 14 Weeks After the Third Administration(At Day 85, 113 and Day 155.)
- MD Part: Trough Levels of BI 754132 Before Second Administration (Cmin,1)(Up to 29 days.)