[Translation] A randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial evaluating the safety, tolerability, and pharmacokinetics of human keratinocyte growth factor-2 (hKGF-2) eye drops in healthy participants under single and multiple doses.
主要目的:
1)评价健康参与者单次和多次滴眼给予hKGF-2滴眼液的安全性及耐受性。
次要目的:
1)评价健康参与者单次和多次滴眼给予hKGF-2滴眼液血清中的药代动力学特征;
2)评价健康参与者单次和多次滴眼给予hKGF-2滴眼液的免疫原性。
探索性目的:
1)探索健康参与者单次和多次滴眼给予hKGF-2滴眼液的局部药代动力学特征。
[Translation] Primary Objective:
1) To evaluate the safety and tolerability of single and multiple eye drops of hKGF-2 eye drops in healthy participants.
Secondary Objectives:
1) To evaluate the serum pharmacokinetic characteristics of single and multiple eye drops of hKGF-2 eye drops in healthy participants;
2) To evaluate the immunogenicity of single and multiple eye drops of hKGF-2 eye drops in healthy participants.
Exploratory Objective:
1) To explore the local pharmacokinetic characteristics of single and multiple eye drops of hKGF-2 eye drops in healthy participants.