NCT07218770终止1 期
A Phase 1/2a Study of REGN7041 (Anti-CD3 Monoclonal Antibody) in Participants With Active Noninfectious Uveitis Affecting the Posterior Segment
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 5
- 主要终点
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study is researching an experimental drug called REGN7041 (also referred to as "study drug"). The study is focused on patients who have active inflammation inside of the eye without any signs of infection.
The aim of the study is to see how safe and tolerable the study drug is. This is the first time the study drug is being tested in humans.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood and the fluid in the eye at different times
- Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-infectious anterior, intermediate, posterior or panuveitis (For anterior uveitis, there must be evidence of inflammation affecting the posterior segment), as defined in the protocol
- •Active disease at baseline, as defined in the protocol
- •Part A only: Best Corrected Visual Acuity (BCVA) of ≤65 and >10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of worse than or equal to 20/50 and better than 20/630) at the screening visit and on day 1
- •Part B only: BCVA of <75 and >10 ETDRS letters (Snellen equivalent of worse than 20/32 and better than 20/630) at the screening visit and on day 1
排除标准
- •BCVA of ≤30 ETDRS letters (Snellen equivalent of 20/250 or worse) at the screening visit and/or on day 1
- •Intraocular Pressure (IOP) <5 mm Hg at the screening visit and/or on day 1
- •IOP >25 mm Hg on day
- •Participants are permitted to take IOP-lowering eye drops
- •Confirmed or suspected infectious uveitis, as defined in the protocol
- •NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
研究组 & 干预措施
Sequential Single Ascending Dose Cohorts
Experimental
干预措施: REGN7041 (Drug)
Sequential Multiple Ascending Dose Cohorts
Experimental
干预措施: REGN7041 (Drug)
结局指标
主要结局
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: Through Week 24
次要结局
- Concentrations of REGN7041 in serum(Through Week 24)
- Incidence of Anti-Drug Antibodies (ADAs) to REGN7041 in serum(Through Week 24)
- Magnitude of ADAs to REGN7041 in serum(Through Week 24)
研究者
研究点 (5)
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