[Translation] To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ASKG712 injection in patients with neovascular age-related macular degeneration in a multicenter, open-label, intravitreal single-dose escalation and multiple-dose escalation study
主要目的:
评价单次和多次玻璃体腔内注射(IVT)ASKG712在新生血管性年龄相关性黄斑变性(nAMD)患者中的安全性和耐受性。
次要目的:
评价单次和多次玻璃体腔内注射ASKG712在新生血管性年龄相关性黄斑变性患者中的药代动力学特征,为II期临床试验的给药方案提供依据。
评价单次和多次玻璃体腔内注射ASKG712在新生血管性年龄相关性黄斑变性患者中免疫原性。
评价单次和多次玻璃体腔内注射ASKG712在新生血管性年龄相关性黄斑变性患者中初步临床疗效。
探索性目的:
探索ASKG712治疗相关的生物标志物。
[Translation] Primary objective:
To evaluate the safety and tolerability of single and multiple intravitreal injections (IVT) of ASKG712 in patients with neovascular age-related macular degeneration (nAMD).
Secondary objective:
To evaluate the pharmacokinetic characteristics of single and multiple intravitreal injections of ASKG712 in patients with neovascular age-related macular degeneration, and provide a basis for the dosing regimen of the Phase II clinical trial.
To evaluate the immunogenicity of single and multiple intravitreal injections of ASKG712 in patients with neovascular age-related macular degeneration.
To evaluate the preliminary clinical efficacy of single and multiple intravitreal injections of ASKG712 in patients with neovascular age-related macular degeneration.
Exploratory objective:
To explore biomarkers related to ASKG712 treatment.