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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Main Who May Qualify: 1. Male or female subjects of any ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months. 2. Diagnosis of RSV infection by any virological means, including a rapid diagnostic point-of-care testing, within 36 hours preceding initial dosing. 3. The onset of RSV infection symptoms should be ≤ 5 days prior to initial dosing. 4. Subject must weigh ≥ 2.5 kg and ≤ 20 kg at screening and be within the normal range for the subject's age, based on local child growth standards. 5. Subject must have a Wang bronchiolitis clinical score ≥ 5. Main Who Should NOT Join This Trial: 1. The subject has taken any restricted medications within 3 days prior to the date of screening or requires any restricted medications during treatment phase (including interferons, ribavirin, or proprietary Chinese medicines with antiviral effects) and has taken any inhaled or systemic glucocorticoids within 24 hours. 2. Subject is known to have co-infection with influenza virus, Mycoplasma, or other respiratory tract pathogens that require targeted clinical treatment . 3. Subject is known to have bacterial pneumonia. 4. Subject with clinical evidence of hepatic decompensation (e.g., liver disease with coagulation abnormalities or encephalopathy). 5. Subject with inborn symptoms of metabolic abnormalities (e.g., mitochondrial diseases, carbohydrate metabolism abnormalities, glycogen accumulation diseases). 6. Subject with chronic or persistent feeding difficulties. 7. The parent or guardian of the subject is an employee of the study investigator or the study facility (such person will be directly involved in the study or any other study administered by the study facility investigator), or a family member of the study investigator or his/her staff. 8. Subject who have participated in clinical trials of other drugs or devices in the 30 days prior to screening. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Main Inclusion criteria: 1. Male or female subjects of any ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months. 2. Diagnosis of RSV infection by any virological means, including a rapid diagnostic point-of-care testing, within 36 hours preceding initial dosing. 3. The onset of RSV infection symptoms should be ≤ 5 days prior to initial dosing. 4. Subject must weigh ≥ 2.5 kg and ≤ 20 kg at screening and be within the normal range for the subject's age, based on local child growth standards. 5. Subject must have a Wang bronchiolitis clinical score ≥ 5. Main Exclusion criteria: 1. The subject has taken any restricted medications within 3 days prior to the date of screening or requires any restricted medications during treatment phase (including interferons, ribavirin, or proprietary Chinese medicines with antiviral effects) and has taken any inhaled or systemic glucocorticoids within 24 hours. 2. Subject is known to have co-infection with influenza virus, Mycoplasma, or other respiratory tract pathogens that require targeted clinical treatment . 3. Subject is known to have bacterial pneumonia. 4. Subject with clinical evidence of hepatic decompensation (e.g., liver disease with coagulation abnormalities or encephalopathy). 5. Subject with inborn symptoms of metabolic abnormalities (e.g., mitochondrial diseases, carbohydrate metabolism abnormalities, glycogen accumulation diseases). 6. Subject with chronic or persistent feeding difficulties. 7. The parent or guardian of the subject is an employee of the study investigator or the study facility (such person will be directly involved in the study or any other study administered by the study facility investigator), or a family member of the study investigator or his/her staff. 8. Subject who have participated in clinical trials of other drugs or devices in the 30 days prior to screening. 9. Subject with any other reason that the investigator deems unsuitable for participation in the study.

Treatments Being Tested

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