A Phase 1a, Multicenter, Open-label, Single-dose, Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 12
- 主要终点
- Percentage of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.
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
Single Ascending Dose Stage
Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D).
干预措施: RO7303359 (Drug)
Expansion Cohort Stage
Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage.
干预措施: RO7303359 (Drug)
Optional Cohort E
An optional additional cohort may be added with the dose not exceed the MTD or MTeD.
干预措施: RO7303359 (Drug)
Optional cohort F
An optional additional cohort may be added with the dose not exceed the MTD or MTeD.
干预措施: RO7303359 (Drug)
结局指标
主要结局
Percentage of Participants With Serious Adverse Events (SAEs)
时间窗: Up to 12 weeks
Percentage of Participants With Ocular Adverse Events
时间窗: Up to 12 weeks
Percentage of Participants With Adverse Events Leading to Study Discontinuation
时间窗: Up to 12 weeks
Percentage of Participants With Adverse Events of Special Interest (AESIs)
时间窗: Up to 12 weeks
Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
时间窗: Baseline, Week 12
Percentage of Participants With Systemic Adverse Events
时间窗: Up to 12 weeks
Percentage of Participants With Dose-limiting Adverse Events (DLAEs),
时间窗: Up to 12 weeks
次要结局
未报告次要终点