A Phase 1, Open-label, Single-dose, Dose-escalation, Safety, Tolerability, and PK Study of Intravitreal ANX007 in Participants With Primary Open-angle Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Safety and tolerability as measured by the occurrence of adverse events
研究概览
简要总结
This is a multi center, open-label, single dose, safety study. Approximately 9 to 15 participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will receive ANX007 administered as single, IVT injections.
详细描述
This is a phase 1, open-label, dose-escalation, safety study evaluating up to 3 dose levels of ANX007 administered as single IVT injections. Approximately 9 to 15 eligible participants are enrolled into one cohort each. All participants receive ANX007 in an open-label manner. The primary objective is to evaluate the safety and tolerability of a single intravitreal (IVT) injection of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the serum pharmacokinetics (PK) and immunogenicity. An exploratory objective will evaluate the pharmacodynamic (PD) effect of ANX007 on serum C1q activity.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18 years and older
- •Diagnosis of primary open-angle glaucoma
- •Intraocular pressure <21 mm Hg on a stable IOP treatment regimen
- •Reliable visual field testing
排除标准
- •BCVA worse than 20/80 in either eye
- •Extensive glaucomatous visual-field damage
- •History of intraocular inflammatory or infectious eye disease in study eye
- •Ocular trauma in study eye within the preceding 6 months
- •History of uncomplicated cataract surgery less than 6 mos prior
- •Any abnormality preventing reliable Tonopen tonometry in study eye
- •Active malignancy within past 5 yrs
- •Previous tx with another humanized monoclonal antibody
- •History of any autoimmune or neurologic disease
- •Concurrent use of glucocorticoid medications
- •Receiving monoamine oxidase inhibitor therapy
结局指标
主要结局
Safety and tolerability as measured by the occurrence of adverse events
时间窗: Day 56
次要结局
- Serum plasma concentration of ANX007 after a single IVT injection.(Day 15)
- Immunogenicity of ANX007 after a single IVT injection.(Day 56)