AK0529: Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
Placebo: Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Beijing | China | Recruiting |
| Beijing Children's Hospital, Capital Medical University | Beijing | China | Recruiting |
| First Hospital of Jilin University | Changchun | China | Recruiting |
| Hunan Provincial People's Hospital | Changsha | China | Recruiting |
| West China Second University Hospital, Sichuan University | Chengdu | China | Recruiting |
| Children's Hospital, Zhejiang University School of Medicine | Hangzhou | China | Recruiting |
| Sanya Central Hospital, Hainan Third People's Hospital | Sanya | China | Recruiting |
| Shanghai Children's Hospital, Shanghai Jiao Tong University | Shanghai | China | Recruiting |
| Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine | Shanghai | China | Recruiting |
| Shengjing Hospital of China Medical University | Shenyang | China | Recruiting |
| Tianjin Children's Hospital(Longyan) | Tianjin | China | Recruiting |
| Tianjin Children's Hospital(Machang) | Tianjin | China | Recruiting |
| Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | China | Recruiting |
| Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China | Recruiting |
| Wuxi Children's Hospital | Wuxi | China | Recruiting |
| First Affiliated Hospital of Xiamen University | Xiamen | China | Recruiting |
| Women and Children's Hospital, and the School of Medicine, Xiamen University | Xiamen | China | Recruiting |
| Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital | Zhongshan | China | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06775405 on ClinicalTrials.gov ↗ ← All trials in China