[Translation] A single-center, randomized, double-blind, placebo-controlled phase I clinical study to evaluate the local (ocular) and systemic safety and tolerability of recombinant human keratinocyte growth factor-2 eye drops (rhKGF-2) in healthy Chinese subjects after single and repeated administration
主要目的:评价在中国健康受试者中单次、多次眼部给予rhKGF-2滴眼液后的局部(眼部)和全身的安全性和耐受性。次要目的:1)评价在中国健康受试者中单次、多次眼部给予rhKGF-2滴眼液后的血液/泪液药代动力学(PK)特征;2)评价rhKGF-2的免疫原性。
[Translation] Primary objective: To evaluate the local (ocular) and systemic safety and tolerability of rhKGF-2 eye drops after single and multiple ocular administration in healthy Chinese subjects. Secondary objectives: 1) To evaluate the blood/tear pharmacokinetic (PK) profile of rhKGF-2 eye drops after single and multiple ocular administration in healthy Chinese subjects; 2) To evaluate the immunogenicity of rhKGF-2.