NCT00973011已完成1 期
A Phase Ia, Multicenter, Open-Label, Single-Dose, Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Safety and tolerability of the study drug
研究概览
简要总结
The Phase Ia, open-label, multicenter study will consist of a single-dose, dose-escalation study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to undertake all scheduled visits and assessments
- •Agreement to use an effective form of contraception for the duration of the study
- •Geographic atrophy (GA) at least 0.75 disc areas in the absence of choroidal neovascularization (CNV)
排除标准
- •Treatment for active systemic infection
- •Predisposition or history of increased risk for infection
- •Active malignancy
- •History of medical conditions, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
- •GA in either eye due to non-AMD causes
- •Active or history of ocular and intraocular conditions in the study eye (except GA)
- •History of vitreoretinal surgery or laser photocoagulation in the study eye
- •Prior treatment for AMD (except vitamins and minerals)
- •History of intravitreal (ITV) drug delivery
- •Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 0
- •Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
研究组 & 干预措施
A
Experimental
干预措施: FCFD4514S (Drug)
结局指标
主要结局
Safety and tolerability of the study drug
时间窗: Through study completion or early study discontinuation
次要结局
- PK parameters of study drug (total exposure, maximum observed serum concentration, and time of maximum observed serum concentration)(Through study completion or early study discontinuation)
研究者
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