[Translation] To evaluate the multicenter, open-label use of ASKG712 injection in patients with neovascular age-related macular degeneration
Safety, tolerability, pharmacokinetics of intravitreal single-dose escalation and multiple-dose escalation
Kinetic and pharmacodynamic studies
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] main purpose:
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 purpose:
To evaluate the pharmacokinetics of single and multiple intravitreal injections of ASKG712 in patients with neovascular age-related macular degeneration, and to provide the basis for the dosing regimen of phase II clinical trials.
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 Purpose:
Explore biomarkers associated with ASKG712 therapy.