A Study of AK0529 in Chinese Infants Hospitalized With RSV

Summary

This is a randomized, double-blind, placebo-controlled, multicenter, phase III study to be conducted in infants hospitalized with RSV infection in China. The main objectives of this study are to investigate the efficacy and safety of AK0529 in Chinese infants.

Timeline

Start

2020-09-22

Primary completion

2022-01-21

Completion

2022-02-02

Outcome

Met primary endpoint

paper The reduction from baseline in the Wang bronchiolitis clinical score at day 3 was significantly greater with ziresovir than with placebo PMID 39321361 ↗

release “在临床三期AirFLO试验中，爱司韦™与安慰剂相比显著降低症状评分（p=0.002）及病毒载量（p=0.006），达到试验主要终点和关键次要终点” arkbiosciences.com ↗

Publications

• Zhang H, Zhao W, Zhang X, Zhang L, Guo R, Huang H, Lin L, Liu F, Chen H, Shen F, Wu J, Huang X, Zhu X, Li F, Zou G, Chien J, Humphries M, Lu Q, Wu JZ, Zhao S, Liu H, Ni X; AIRFLO Study Group. Efficacy and safety of ziresovir in hospitalised infants aged 6 months or younger with respiratory syncytial virus infection in China: findings from a phase 3 randomised trial with 24-month follow-up. Lancet Child Adolesc Health. 2025 May;9(5):325-336. doi: 10.1016/S2352-4642(25)00067-7.
• Zhao S, Shang Y, Yin Y, Zou Y, Xu Y, Zhong L, Zhang H, Zhang H, Zhao D, Shen T, Huang D, Chen Q, Yang Q, Yang Y, Dong X, Li L, Chen Z, Liu E, Deng L, Jiang W, Cheng H, Nong G, Wang X, Chen Y, Ding R, Zhou W, Zheng Y, Shen Z, Lu X, Hao C, Zhu X, Jia T, Wu Y, Zou G, Rito K, Wu JZ, Liu H, Ni X; AIRFLO Study Group. Ziresovir in Hospitalized Infants with Respiratory Syncytial Virus Infection. N Engl J Med. 2024 Sep 26;391(12):1096-1107. doi: 10.1056/NEJMoa2313551.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ziresovir	Small molecule	10 mg	Oral
Subject	Ziresovir	Small molecule	20 mg	Oral
Subject	Ziresovir	Small molecule	40 mg	Oral

Indications