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Study identifier: NCT06775405 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Respiratory Synctial Virus Infections  ·  Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.

PhasePhase 3
Planned participants180
Who can joinAll sexes, 1 Month to 24 Months
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Chao Yu, Master  ·  +86 021-50681677  ·  chao.yu@arkbiosciences.com

Always discuss trial participation with your own doctor first.

Locations (18)

Beijing Children's Hospital, Capital Medical UniversityBeijing, ChinaRecruiting
Beijing Children's Hospital, Capital Medical UniversityBeijing, ChinaRecruiting
First Hospital of Jilin UniversityChangchun, ChinaRecruiting
Hunan Provincial People's HospitalChangsha, ChinaRecruiting
West China Second University Hospital, Sichuan UniversityChengdu, ChinaRecruiting
Children's Hospital, Zhejiang University School of MedicineHangzhou, ChinaRecruiting
Sanya Central Hospital, Hainan Third People's HospitalSanya, ChinaRecruiting
Shanghai Children's Hospital, Shanghai Jiao Tong UniversityShanghai, ChinaRecruiting
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of MedicineShanghai, ChinaRecruiting
Shengjing Hospital of China Medical UniversityShenyang, ChinaRecruiting
Tianjin Children's Hospital(Longyan)Tianjin, ChinaRecruiting
Tianjin Children's Hospital(Machang)Tianjin, ChinaRecruiting

+ 6 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06775405