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A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants
Led by Shanghai Ark Biopharmaceutical Co., Ltd. · Updated on 2025-01-15
180
Participants Needed
18
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female infants aged 1 to 24 months (adjusted for prematurity)
- Confirmed RSV infection by virological testing within 36 hours before first dose
- RSV symptoms started 5 days or less before initial dosing
- Weight between 2.5 kg and 20 kg, within normal growth range for age
- Wang bronchiolitis clinical score of 5 or higher
You will not qualify if you...
- Use of restricted medications (including interferons, ribavirin, antiviral Chinese medicines) within 3 days before screening or during treatment
- Use of inhaled or systemic glucocorticoids within 24 hours
- Known co-infection with influenza virus, Mycoplasma, or other respiratory pathogens needing targeted treatment
- Known bacterial pneumonia
- Evidence of liver failure or severe liver disease
- Inborn metabolic disorders (e.g., mitochondrial diseases, glycogen storage disease)
- Chronic or persistent feeding problems
- Parent or guardian employed by the study investigator or facility staff
- Participation in other drug or device clinical trials within 30 days prior to screening
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Beijing Children's Hospital, Capital Medical University
Beijing, China
Actively Recruiting
2
Beijing Children's Hospital, Capital Medical University
Beijing, China
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3
First Hospital of Jilin University
Changchun, China
Actively Recruiting
4
Hunan Provincial People's Hospital
Changsha, China
Actively Recruiting
5
West China Second University Hospital, Sichuan University
Chengdu, China
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6
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, China
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7
Sanya Central Hospital, Hainan Third People's Hospital
Sanya, China
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8
Shanghai Children's Hospital, Shanghai Jiao Tong University
Shanghai, China
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9
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, China
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10
Shengjing Hospital of China Medical University
Shenyang, China
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11
Tianjin Children's Hospital（Longyan）
Tianjin, China
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12
Tianjin Children's Hospital（Machang）
Tianjin, China
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13
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, China
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14
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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15
Wuxi Children's Hospital
Wuxi, China
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16
First Affiliated Hospital of Xiamen University
Xiamen, China
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17
Women and Children's Hospital, and the School of Medicine, Xiamen University
Xiamen, China
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18
Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital
Zhongshan, China
Actively Recruiting
Research Team
C
Chao Yu, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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