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A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants
Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
Summary
Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of hospitalization for severe respiratory infections in infants. Serious respiratory problems such as pneumonia caused by RSV are one of the leading causes of death from respiratory diseases in infants. AK0529 targets the Pre-F (fusion) protein on the surface of the viral envelope. Specifically, it prevents the virus from invading uninfected cells and inhibits the fusion between host cells by inhibiting the fusion of the F (fusion) proteins on the surface of the RSV envelope, thus providing the effects of anti-RSV infection. This is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of AK0529 in hospitalized infants aged 1 to 24 months with RSV infection. Considering the benefits of AK0529 in the population with RSV infection, hospitalized infants with moderate to severe RSV infection were selected as the target population for this study.
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Confirmatory Study to Evaluate the Efficacy, Safety, Tolerability, and Antiviral Activity of Repeated Oral Administration of AK0529 in Hospitalized Infants with Respiratory Syncytial Virus Infection
Key Details
Gender
All
Age Range
1 Month - 24 Months
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2024-02-29
Completion Date
2025-09
Last Updated
2025-01-15
Healthy Volunteers
No
Conditions
Interventions
AK0529
Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
Placebo
Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
Locations (18)
Beijing Children's Hospital, Capital Medical University
Beijing, China
Beijing Children's Hospital, Capital Medical University
Beijing, China
First Hospital of Jilin University
Changchun, China
Hunan Provincial People's Hospital
Changsha, China
West China Second University Hospital, Sichuan University
Chengdu, China
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, China
Sanya Central Hospital, Hainan Third People's Hospital
Sanya, China
Shanghai Children's Hospital, Shanghai Jiao Tong University
Shanghai, China
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
Tianjin Children's Hospital(Longyan)
Tianjin, China
Tianjin Children's Hospital(Machang)
Tianjin, China
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, China
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Wuxi Children's Hospital
Wuxi, China
First Affiliated Hospital of Xiamen University
Xiamen, China
Women and Children's Hospital, and the School of Medicine, Xiamen University
Xiamen, China
Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital
Zhongshan, China