A Study of AK0529 in Chinese Infants Hospitalized With RSV

PHASE3CompletedINTERVENTIONAL
Enrollment

311

Participants

Timeline

Start Date

September 22, 2020

Primary Completion Date

January 21, 2022

Study Completion Date

February 2, 2022

Conditions
Respiratory Syncytial Virus Infections
Interventions
DRUG

AK0529

AK0529 capsule will be orally administered at the twice-daily dosing levels of 10 mg, 20 mg, or 40 mg for five days based on the patient's weight.

DRUG

Matching placebo of AK0529

The placebo capsule was made with the same smell and appearance as AK0529 but without the active ingredients and will be orally administered per the same treatment schedule as those in the experimental arm.

Trial Locations (28)

100045

Beijing Children's Hospital, Beijing

100191

Peking University Third Hospital, Beijing

110004

Shengjing Hospital of China Medical University, Shengyang

130021

The First Bethune Hospital of Jilin University, Changchun

200062

Children's Hospital of Shanghai, Shanghai

200127

Shanghai Children's Medical Center, Shanghai

210008

Children's Hospital of Nanjing Medical University, Nanjing

210029

Jiangsu Province Hospital, Nanjing

214023

Wuxi Children's Hospital, Wuxi

215002

Children's Hospital of Soochow University, Suzhou

252000

Liaocheng People's Hospital, Liaocheng

300074

Tianjin Children's Hospital, Tianjin

310030

The Children's Hospital of Zhejiang University School of Medicine, Hangzhou

325027

The Second Affiliated Hospital and Yuying Children's Hospital of WMU, Wenzhou

330006

Jiangxi Provincial Children's Hospital, Nanchang

361003

The First Affiliated Hospital of Xiamen University, Xiamen

361100

Xiamen Maternity and Child Healthcare Hospital, Xiamen

401122

Children's Hospital of Chongqing Medical University, Chongqing

410005

Hunan Provincial People's Hospital, Changsha

430016

Wuhan Children's Hospital, Wuhan

450018

Henan Children's Hospital, Zhengzhou

450052

The Third Affiliated Hospital of Zhengzhou University, Zhengzhou

510623

Guangzhou Women and Children's Medical Center, Guangzhou

518026

Shenzhen Children's Hospital, Shenzhen

528402

Boai Hospital of Zhongshan, Zhongshan

530021

The First Affiliated Hospital of Guangxi Medical University, Nanjing

572000

Hainan Third People's Hospital, Sanya

610041

West China Women's and Children's Hospital, Chengdu

All Listed Sponsors
lead

Shanghai Ark Biopharmaceutical Co., Ltd.

INDUSTRY

NCT04231968 - A Study of AK0529 in Chinese Infants Hospitalized With RSV | Biotech Hunter | Biotech Hunter