Shenzhen Kangzhe Weisheng Pharmaceutical Development Co., Ltd.

Phase I: Primary objective: To evaluate the safety and tolerability of single or multiple IVT injections of Y400 in nAMD subjects, determine the maximum tolerated dose of Y400, and recommend the dose for Phase 2 study (RP2D). Secondary objective: To evaluate the pharmacokinetic characteristics (PK) of Y400 in the whole body during single and multiple IVT injections of nAMD subjects; to evaluate the preliminary efficacy of single and multiple IVT injections of Y400 in nAMD subjects. Exploratory objective: To evaluate the immunogenicity of single and multiple IVT injections of Y400 in nAMD subjects and its impact on the PK and safety of Y400. Phase II: Primary objective: To evaluate the efficacy and safety of Y400 in the treatment of nAMD by IVT injection compared with aflibercept, and to propose the optimal dose and dosing regimen for further clinical research in the later stage. Secondary objective: To evaluate the PK characteristics of multiple IVT injections of Y400 in the whole body. Exploratory objective: To evaluate the immunogenicity of Y400 and its potential impact; to explore the correlation between blood concentration of Y400 and efficacy (dose-effect relationship).