[Translation] A multicenter, dose-escalation and dose-expansion Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SCT520FF in the treatment of patients with neovascular age-related macular degeneration
(1) Ia期
主要目的: 评估SCT520FF单次给药安全耐受性,确定最大耐受剂量(MTD)。
次要目的: 评估SCT520FF单次给药初步疗效; 评估SCT520FF单次给药PK、PD特征; 评估SCT520FF免疫原性。
(2) Ib期
主要目的: 评估SCT520FF多次给药安全耐受性,确定MTD。
次要目的: 评估SCT520FF多次给药初步疗效; 评估SCT520FF多次给药PK、PD特征; 评估SCT520FF免疫原性。
[Translation] (1) Phase Ia
Primary purpose: To evaluate the safety and tolerability of a single dose of SCT520FF and determine the maximum tolerated dose (MTD).
Secondary purpose: To evaluate the preliminary efficacy of a single dose of SCT520FF; To evaluate the PK and PD characteristics of a single dose of SCT520FF; To evaluate the immunogenicity of SCT520FF.
(2) Phase Ib
Primary purpose: To evaluate the safety and tolerability of multiple doses of SCT520FF and determine the MTD.
Secondary purpose: To evaluate the preliminary efficacy of multiple doses of SCT520FF; To evaluate the PK and PD characteristics of multiple doses of SCT520FF; To evaluate the immunogenicity of SCT520FF.