A Phase 1, Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of a Single Intravitreal Injection of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 8
- 主要终点
- Ocular and systemic safety and tolerability of a single intravitreal injection of UBX1325 evaluated by the incidence of dose limiting toxicities (DLTs) and treatment emergent adverse events (TEAEs)
研究概览
简要总结
A study to evaluate safety, tolerability, and pharmacokinetics of a single intravitreal injection of UBX1325 in patients diagnosed with diabetic macular edema (DME) or neovascular Age-Related Macular Degeneration.
详细描述
This is a Phase 1, open-label, first-in-human (FIH), single-ascending dose (SAD) study consisting of approximately 4 cohorts. The total number of patients will be at least 3 per cohort plus 3 additional patients in the maximum tolerated dose (MTD) cohort in order to address the primary objective. Up to an additional 6 nAMD patients will be enrolled in the highest dose cohort. A single dose of UBX1325 will be administered intravitreally and all patients will be followed for approximately 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •nAMD patients who, in the opinion of the Investigator, are inadequately responding to or failed current treatment options.
- •Active choroidal neovascularization (CNV) associated with age-related macular degeneration as evidenced on FA and SD-OCT at Day 1, including presence of intraretinal or subretinal fluid.
- •BCVA in the study eye (most affected) of 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or worse at screening and on Day
- •Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.
排除标准
- •Any ocular/intraocular/periocular infection or inflammation in either eye in the past 4 weeks prior to screening.
- •Subretinal hemorrhage with bleeding area ≥4 disc area in the study eye
- •Concomitant therapy with anti-VEGF therapies (e.g., Avastin®, Lucentis®, or Eylea®) or previous use of these agents in the study eye within approximately 28 days of study enrollment
- •Any retinovascular disease or retinal degeneration other than nAMD in the study eye.
- •History of systemic and intraocular steroid use for 6 months prior to Day
- •The use of intravitreal nonbiodegradable steroid implants (ex. Iluvien®, Yutiq®, Retisert®) is prohibited.
- •Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging.
- •Any uncontrolled medical condition that, in the opinion of the investigator, would preclude participation in this study.
研究组 & 干预措施
Treatment with UBX1325
UBX1325, single intravitreal injection, ascending dose
干预措施: UBX1325 (Drug)
结局指标
主要结局
Ocular and systemic safety and tolerability of a single intravitreal injection of UBX1325 evaluated by the incidence of dose limiting toxicities (DLTs) and treatment emergent adverse events (TEAEs)
时间窗: 24 weeks
次要结局
- Plasma concentration of UBX1325 following a single intravitreal injection(up to 24 hours post dose)