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RECRUITING
NCT06775405
PHASE3

A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants

Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

AK0529

Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral

DRUG

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