[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical study on the safety and efficacy of GP681 tablets in the treatment of people at high risk of influenza complications
主要研究目的:
通过测量存在流感并发症高风险人群的流感症状缓解时间,评估GP681片与安慰剂相比治疗存在流感并发症高风险人群的有效性。
次要研究目的:
1)通过其他次要终点指标评估GP681片治疗存在流感并发症高风险人群的有效性;
2)评估GP681片治疗存在流感并发症高风险人群的安全性。
3)评估GP681片治疗存在流感并发症高风险人群后的药代动力学(PK)特征,并结合前期临床研究数据建立该特征人群相应的暴露应答模型。
[Translation] Main study objectives:
By measuring the time of influenza symptom relief in people at high risk of influenza complications, evaluate the effectiveness of GP681 tablets compared with placebo in treating people at high risk of influenza complications.
Secondary study objectives:
1) Evaluate the effectiveness of GP681 tablets in treating people at high risk of influenza complications through other secondary endpoints;
2) Evaluate the safety of GP681 tablets in treating people at high risk of influenza complications.
3) Evaluate the pharmacokinetic (PK) characteristics of GP681 tablets after treating people at high risk of influenza complications, and establish the corresponding exposure response model for this characteristic population in combination with previous clinical research data.