Phase I Clinical Trial of Recombinant Humanized Anti-vegf Monoclonal Antibody Single Vitreous Injection for Safety, Tolerance, PK and Pharmacodynamics in nAMD Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- JY028 related incidence of ocular and systemic adverse events and serious adverse events
研究概览
简要总结
Phase I clinical trial on safety, tolerance, pharmacokinetics (PK) and pharmacodynamics of recombinant human anti-VEGF monoclonal antibody injection in patients with neovascular (wet) age-related macular degeneration
详细描述
Test drug:Recombinant humanized anti VEGF monoclonal antibody injection; Research Phase:Phase I; Subjects:Subjects with neovascular (wet) age-related macular degeneration; Number of Subjects:24; Trial design:Single center, non randomized, open, single arm, single dose, dose escalation; Research objective:to rearch the safety and tolerance of JY028 injection;to rearch PK of JY028 injection;to observe the efficacy of JY028 in the treatment of nAMD;to rearch the relationship between plasma VEGF concentration and JY028 concentration. to rearch immunogenicity of JY028;
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient volunteered to participate and signed the informed consent
- •No more than 50 years of age and less than 75 years of age, male or female
- •Diagnosed as nAMD
- •The optimal corrected visual acuity of the target eye ETDRS should be no more than 50 letters, and the optimal corrected visual acuity of the opposite eye should be no more than 34 letters
- •The target eye pressure is no more than 25mmHg, which can be controlled by drugs
- •A normal coagulation function: the platelet count is 100 x 10 ^ 9-300x 10^10 / L, thrombin time, prothrombin time within the normal range.
排除标准
- •Choroid polypoid angiopathy (PCV)
- •There are other obvious eye diseases/conditions (such as diabetic retinopathy, cataract, abnormal eyelid, uncontrolled glaucoma, eye active inflammation, etc.)
- •CNV caused by other causes other than nAMD, such as diabetic retinopathy, vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc
- •The target eye has received any intraocular surgery or laser therapy within 3 months prior to enrollment
- •Any eye treated with antiangiogenic drugs within 3 months prior to baseline visit
- •Patients with active eye infections, such as conjunctivitis, keratitis, sclerotic, blepharitis, endophthalmitis or uveitis
- •Persons with a history of myocardial infarction and/or cerebral infarction or other active or acute cardiovascular diseases
- •HIV antibody/hiv-p24 antigen, any of the positive subjects in the treponema pallidum antibody
- •Active HBsAg carriers (conditions must be met: HBsAg positive, HBV DNA positive, ALT higher than normal upper limit)
- •Patients with HCV (the following conditions must be met: lgM positive anti-hcv antibody, ALT higher than the upper limit of normal value)
- •Fluorescein sodium allergy
- •Allergy to anti-vegf monoclonal antibodies or humanized monoclonal antibodies
- •Patients who participated in other clinical trials within 3 months
- •Patients who took NSAIDs and aspirin or other anticoagulant or platelet drugs within 1 month before enrollment
- •An unhealed wound, ulcer, fracture, or other related medical condition
- •Patients with uncontrollable hypertension, with systolic blood pressure of > 140mmHg and diastolic blood pressure of > 90mmHg
- •Patients with uncontrollable clinical diseases or problems (such as serious mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors)
- •Pregnant and lactating women and those who cannot take contraceptive measures
- •According to the researcher, it is not suitable for the candidate -
研究组 & 干预措施
Experimental
Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;
干预措施: Experimental (Drug)
结局指标
主要结局
JY028 related incidence of ocular and systemic adverse events and serious adverse events
时间窗: 13 weeks
JY028 related incidence of ocular and systemic adverse events and serious adverse events
次要结局
- BCVA(13 weeks)
- AUC0-t、AUCinf(13 weeks)
- Tmax(13 weeks)
- Cmax(13 weeks)