A First-in-human, Prospective Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Outcomes of SZN-8141 in Diabetic Macular Edema
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 9
- 主要终点
- Incidence and severity of treatment-emergent adverse events
研究概览
简要总结
DUET (Cl-8141-1001) is a first-in-human clinical trial evaluating the safety, tolerability, pharmacokinetics (how the body processes the study drug), and preliminary biological activity of SZN-8141 in people with diabetic macular edema (DME). In this study, small groups of participants with DME (approximately three participants per dose group) will receive a single injection of SZN-8141 into the eye and will be followed for approximately 3 months.
During the trial, participants will undergo regular assessments to monitor their overall health and eye condition. These assessments include eye examinations, vision testing, retinal imaging, laboratory testing, and blood sample collection to measure levels of SZN-8141 in the bloodstream and to assess whether the body develops anti-drug antibodies.
The trial uses an ascending-dose design, in which successive groups of participants receive increasing dose levels of SZN-8141. Safety and tolerability data from each dose group will be reviewed before the next higher dose level is evaluated.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 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
- •Age ≥18 years and ≤90 years old
- •Documented diagnosis of diabetes mellitus (type 1 or 2), as defined by the American Diabetes Association or per World Health Organization (WHO) criteria
- •Hemoglobin A1C (HbA1c) of ≤12% for ≤60 days before Day 1
- •Macular thickening secondary to DME involving the center of the fovea with CST ≥325 μm on OCT as determined by the central reading center at the screening visit
- •Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
- •BCVA of 73-25 ETDRS letters inclusive (20/40-20/200 approximate Snellen equivalent), using the ETDRS protocol at the initial testing distance of 4 m on Day 1
- •Treatment naïve and previously treated participants with protocol specified drug washout
排除标准
- •Be pregnant or breastfeeding
- •Active cancer within the past 12 months
- •Stroke (cerebral vascular accident) or myocardial infarction <6 months before Day 1
- •High risk proliferative diabetic retinopathy (PDR) in the study eye
- •Any treatment with panretinal photocoagulation or macular laser in the study eye
- •Any history of idiopathic or immune-mediated uveitis in either eye
- •Active ocular inflammation or suspected or active ocular or periocular infection in either eye on Day 1
- •History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or intraocular glaucoma surgery in the study eye
- •Any planned surgery in the study eye during the course of the study
- •Uncontrolled glaucoma
- •Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis at any time during the trial
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
SZN-8141 Single Ascending Dose Level 1
Participants will receive a single dose of SZN-8141 for Injection
干预措施: SZN-8141 for Injection (Biological)
SZN-8141 Single Ascending Dose Level 2
Participants will receive a single dose of SZN-8141 for Injection
干预措施: SZN-8141 for Injection (Biological)
SZN-8141 Single Ascending Dose Level 3
Participants will receive a single dose of SZN-8141 for Injection
干预措施: SZN-8141 for Injection (Biological)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events
时间窗: Up to 12 weeks
次要结局
- Change in Best Corrected Visual Acuity from Baseline(Up to 12 weeks)
- Changes in Central Subfield Thickness from Baseline(Up to 12 weeks)
- Systemic Drug concentrations of SZN-8141(Up to 12 weeks)
- Incidence of anti-drug antibodies against SZN-8141(Up to 12 weeks)