[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety, tolerability, antiviral activity, preliminary clinical efficacy and pharmacokinetic characteristics of KY0467 granules in children aged 2 to 11 years with hand, foot and mouth disease
主要目的:
1、评估儿童手足口病患者口服KY0467颗粒的安全性和耐受性
2、确定KY0467颗粒治疗患儿的合适后续推荐剂量(或剂量范围)
次要目的:
1、初步评估KY0467颗粒对于患儿临床症状/体征的改善
2、初步评估KY0467颗粒在患儿体内抗EV-A71病毒活性
3、评价患儿口服KY0467颗粒的药代动力学特征
[Translation] Main objectives:
1. To evaluate the safety and tolerability of oral KY0467 granules in children with hand, foot and mouth disease
2. To determine the appropriate subsequent recommended dose (or dose range) of KY0467 granules for treating children
Secondary objectives:
1. To preliminarily evaluate the improvement of clinical symptoms/signs of children with KY0467 granules
2. To preliminarily evaluate the anti-EV-A71 viral activity of KY0467 granules in children
3. To evaluate the pharmacokinetic characteristics of oral KY0467 granules in children