[Translation] A randomized, double-blind, parallel, positive-controlled phase I clinical trial comparing the pharmacokinetic characteristics, safety and tolerability of JL14002 monoclonal antibody injection and ranibizumab injection in patients with wet age-related macular degeneration (wAMD)
主要研究目的:评价 wAMD 患者玻璃体腔内注射 JL14002 单抗注射液或雷珠单抗注射液后的药代动力学(PK)特征。
次要研究目的 :1) 评价wAMD患者玻璃体腔内注射JL14002单抗注射液或雷珠单抗注射液后的安全性和耐受性; 2) 评价wAMD患者玻璃体腔内注射JL14002 单抗注射液或雷珠单抗注射液后的免疫原性;3) 评价wAMD患者玻璃体腔内注射JL14002单抗注射液或雷珠单抗注射液的药效学特征; 4) 评价wAMD患者玻璃体腔内注射JL14002 单抗注射液或雷珠单抗注射液后的初步有效性。
[Translation] Primary study objectives: To evaluate the pharmacokinetic (PK) characteristics of JL14002 monoclonal antibody injection or ranibizumab injection after intravitreal injection in patients with wAMD.
Secondary study objectives: 1) To evaluate the safety and tolerability of JL14002 monoclonal antibody injection or ranibizumab injection after intravitreal injection in patients with wAMD; 2) To evaluate the immunogenicity of JL14002 monoclonal antibody injection or ranibizumab injection after intravitreal injection in patients with wAMD; 3) To evaluate the pharmacodynamic characteristics of JL14002 monoclonal antibody injection or ranibizumab injection after intravitreal injection in patients with wAMD; 4) To evaluate the preliminary efficacy of JL14002 monoclonal antibody injection or ranibizumab injection after intravitreal injection in patients with wAMD.