A Phase I Study of GenSci148 Intravitreal Injection for Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion (GenSci148-101)
A Phase I, Open-label, Dose-escalation, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intravitreal Injection of GenSci148 in Participants With Neovascular Age-related Macular Degeneration (nAMD) and Multiple Intravitreal Injections of GenSci148 in Participants With nAMD, Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
研究概览
详细说明
This is a Phase I, multicenter, open-label, dose-escalation study conducted in 2 parts to evaluate the safety, tolerability, PK and PD profiles, and immunogenicity, as well as the preliminary efficacy of intravitreal injection of GenSci148 in participants with nAMD, DME and RVO.
Part 1 (Single Ascending Dose, SAD): Conducted in participants with nAMD. Four dose levels (1 mg/eye, 3 mg/eye, 7 mg/eye, and 10 mg/eye) are planned, administered via a single IVT injection. Dose escalation is determined by the Safety Review Committee (SRC) based on safety, tolerability, PK, PD, and other available data.
Part 2 (Multiple Ascending Dose, MAD): Conducted in participants with nAMD, DME, and RVO. Three dose levels (low, medium, and high) are planned. Participants will receive multiple IVT injections according to the study schedule. Disease activity assessment will be performed during follow-up, and participants meeting retreatment criteria may receive additional doses of GenSci148.
Safety assessments include adverse events, physical examinations, laboratory tests, vital signs, ECG, and ophthalmic examinations (BCVA, IOP, slit-lamp examination, , etc.). PK/PD and immunogenicity samples are collected at predefined time points.
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Gaohui Zhou
- 电话号码：+86-021-64320070
- 邮箱：zhougaohui@genscigroup.com
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200080
- Shanghai General Hospital
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接触：
- Xiaodong Sun
- 电话号码：+86 13386259752
- 邮箱：xdsun@sjtu.edu.cn
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Able to understand the study and provide written informed consent prior to any study-related procedures.
- Willing and able to comply with scheduled visits, treatment plan, and study procedures.
- Best corrected visual acuity (BCVA) of 24 to 78 letters (inclusive) in the study eye, and BCVA ≥ 24 letters in the fellow eye.
Exclusion Criteria:
- Prior or current contraindicated ophthalmic treatments in study or fellow eye per protocol.
- Refractive error > ±8.0 diopters in the study eye.
- Anterior segment neovascularization or vitreous hemorrhage in the study eye.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：GenSci148 Intravitreal Injection
Participants receive intravitreal injections of GenSci148 at escalating dose levels.
Part 1: single ascending dose (1 mg, 3 mg, 7 mg, 10 mg per eye).
Part 2: multiple ascending doses in nAMD, DME, and RVO participants.
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GenSci148 is a fusion protein that simultaneously targets VEGF-A, VEGF-C, VEGF-D, and Ang-2.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence and severity of treatment-emergent adverse events (TEAEs)
大体时间：43 days(Part 1) and 40 weeks (Part 2)
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TEAEs include ocular and systemic adverse events, graded by severity and relationship to study drug.
Safety assessments include physical examination, vital signs, laboratory tests, ECG, and ophthalmic examinations.
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43 days(Part 1) and 40 weeks (Part 2)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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