A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants
NCT ID: NCT06775405
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2024-02-29
2025-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of AK0529 in Chinese Infants Hospitalized With RSV
NCT04231968
A Study of AK0529 in Adults Patients Hospitalized With RSV Infection
NCT06942299
Anti-RSV Study in Chinese Patients (ASCENT)
NCT03699202
Viral Inhibition in Children for Treatment of RSV
NCT02654171
Safety, Tolerability and PK Study of AK0529 in Healthy Human
NCT02297594
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study plans to enroll 180 infants aged 1 to 24 months with RSV infection. Eligible subjects will be randomized in a 1:1 ratio (AK0529: placebo). These subjects will receive the study drug twice daily for 5 consecutive days and the dose depends on subject's weight range.
Each subject in this study will undergo a visit schedule comprising a screening period of 36 hours before the first dose, a 5-day double-blinded treatment period, and a 9-day safety follow-up period after the last dose of treatment. The expected duration of participation for each subject will not exceed 17 days.
Infants successfully enrolled in this study will take the medication every 12 hours for 5 consecutive days, in total 10 doses. Investigators will regularly score the infants using the Wang bronchiolitis clinical score which is the primary endpoint. Additionally, nasopharyngeal aspirates samples will be collected from the infants for virological testing before the first dose on Days 1 to 5, on Day 6, and on Day 14.
Safety and tolerability assessments in this study will include evaluations of adverse events (AEs)/serious adverse events (SAEs), vital signs and blood oxygen saturation (SpO2) levels, physical examinations, clinical laboratory tests, and electrocardiogram (ECG) findings.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active drug
The participants will receive AK0529 of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5.
AK0529
Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
Placebo
The participants will receive placebo of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5.
Placebo
Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AK0529
Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
Placebo
Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
1 Month
24 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Ark Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Shunying Zhao, MD, PhD
Role: backup
Xin Ni, MD, PhD
Role: backup
Shunying Zhao
Role: backup
Xin Ni
Role: backup
Hongmei Qiao
Role: backup
Lili Zhong
Role: backup
Hanmin Liu
Role: backup
Zhimin Chen
Role: backup
Hua Zhang
Role: backup
Xiaoyan Dong
Role: backup
Yong Yin
Role: backup
Yunxiao Shang
Role: backup
Yongsheng Xu
Role: backup
Yingxue Zou
Role: backup
Hailin Zhang
Role: backup
Xiaoxia Lu
Role: backup
Ling Li
Role: backup
Yungang Yang
Role: backup
Tong Shen
Role: backup
Dongming Huang
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AK0529-2007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.