[Translation] A single-center, randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple eye drops of G01 eye drops in healthy subjects
主要目的 评价在健康受试者中单/多次眼部给予G01滴眼液后的局部(眼部)和全身的安全性和耐受性;
次要目的 评价在健康受试者中单/多次眼部给予G01滴眼液后可检测到的血药浓度;若检测到足够数量的系统暴露量,评价不同浓度G01滴眼液在健康成年受试者中的药代动力学(PK)特征; 评价在健康成年受试者中单/多次眼部给予G01滴眼液后的免疫原性。
[Translation] Primary objective To evaluate the local (ocular) and systemic safety and tolerability of G01 eye drops after single/multiple ocular administration in healthy subjects; Secondary objective To evaluate the detectable blood drug concentration after single/multiple ocular administration of G01 eye drops in healthy subjects; if sufficient systemic exposure is detected, evaluate the pharmacokinetic (PK) characteristics of different concentrations of G01 eye drops in healthy adult subjects; Evaluate the immunogenicity of G01 eye drops after single/multiple ocular administration in healthy adult subjects.