JY028 Single Vitreous Injection in a Phase 1 Clinical Trial in nAMD Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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;

Official Title
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Phase I Clinical Trial of Recombinant Humanized Anti-vegf Monoclonal Antibody Single Vitreous Injection for Safety, Tolerance, PK and Pharmacodynamics in nAMD Patients

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: Experimental


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. The patient volunteered to participate and signed the informed consent 2. No more than 50 years of age and less than 75 years of age, male or female 3. Diagnosed as nAMD 4. 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 5. The target eye pressure is no more than 25mmHg, which can be controlled by drugs 6. A normal coagulation function: the platelet count is 100 x 10 ^ 9-300x 10^10 / L, thrombin time, prothrombin time within the normal range. - Exclusion Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month; | Drug: Experimental<br>* Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;<br>* Other names: intravitreous injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| JY028 related incidence of ocular and systemic adverse events and serious adverse events | JY028 related incidence of ocular and systemic adverse events and serious adverse events | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum blood drug concentration | 13 weeks | 
| Tmax | Peak time of blood drug concentration | 13 weeks | 
| BCVA | The best corrected visual acuity change | 13 weeks | 
| AUC0-t、AUCinf | The area under the plasma concentration time curves | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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New vascular macular degeneration