A Phase 1b Open-Label, Multiple Ascending Dose Study of the Safety, Tolerability, and Biological Activity of Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 10
- 主要终点
- Adverse Events
研究概览
简要总结
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
详细描述
This is an open label, multiple ascending dose (MAD) study, in which the safety of THN391 will be assessed in escalating doses. This study will enroll a total of approximately 21 participants into 3 sequential dose-escalating cohorts. Participants will receive 3 monthly THN391administrations.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- •18 to 80 years of age (inclusive at the time of informed consent).
- •Diagnosis of Diabetic Macular Edema (DME)
- •Vision loss in the study eye
排除标准
- •Be pregnant or breastfeeding
- •Cataract surgery or any other previous ocular surgery in the study eye within 3 months before Screening
- •Any other condition except for DME that could affect interpretation of study assessments
研究组 & 干预措施
Cohort 3
THN 391 (high dosage), IVT injection
干预措施: THN391 (Drug)
Cohort 1
THN 391 (low dosage), IVT injection
干预措施: THN391 (Drug)
Cohort 2
THN 391 (medium dosage), IVT injection
干预措施: THN391 (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 16 weeks following first dose administration
Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities
次要结局
- Change in Visual Acuity(Up to 16 weeks following first dose administration)
- Change in Retinal Edema(Up to 16 weeks following first dose administration)