[Translation] A single-center, randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of single/multiple administrations of SQ-22031 eye drops in healthy subjects
主要目的:
1)评价SQ-22031滴眼液在健康受试者中单次/多次给药的安全性和耐受性。
次要目的:
1)评价SQ-22031滴眼液在健康受试者中单次/多次给药的局部和全身暴露量,评估药物的药代动力学特征。
2)评价SQ-22031滴眼液在健康受试者中单次/多次给药后的免疫原性。
[Translation] Primary objectives:
1) To evaluate the safety and tolerability of single/multiple administration of SQ-22031 eye drops in healthy subjects.
Secondary objectives:
1) To evaluate the local and systemic exposure of SQ-22031 eye drops in healthy subjects after single/multiple administration and to assess the pharmacokinetic characteristics of the drug.
2) To evaluate the immunogenicity of SQ-22031 eye drops after single/multiple administration in healthy subjects.