Testing a new influenza treatment for children aged 2 to 11
A Phase III, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate Pharmacokinetics, Safety and Efficacy of ADC189 Tablets/Granules in Children 2-11 Years Old With Influenza
This study is testing a new flu treatment for kids aged 2 to 11 to see if it works better than existing options.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 2 Years to 11 Years |
| Sex | All |
| Sponsor | Jiaxing AnDiCon Biotech Co.,Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06507813 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of ADC189, a new treatment for influenza, in children aged 2 to 11 years. It is a multicenter, randomized, double-blind, controlled Phase III study that compares ADC189 tablets and granules against Baloxavir Marboxil and placebo. The study aims to determine how well ADC189 works and its pharmacokinetics after a single oral dose in young children diagnosed with influenza. The trial is crucial as it seeks to provide an effective treatment option for younger children who currently have limited options.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 11 years who have been diagnosed with Influenza A or B and have had symptoms for no more than 48 hours.
Not a fit: Patients with severe influenza or those with other acute respiratory infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safe and effective option for young children suffering from influenza.
How similar studies have performed: Other studies have shown success with antiviral treatments for influenza, but this specific approach with ADC189 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 1. Patients aged 2 to 11 years at screening, both sex; * 2. Patients were diagnosed with Influenza A Vairus Infection/Influenza B Virus Infection. * 3. Parents willing and able to comply with study requirements, under the judgment of investigators . * 4. Onset of symptoms no more than 48 hours before presentation for screening. Key Exclusion Criteria: * 1. Patients with severe influenza. * 2. Pregnant or breast-feeding females * 3. Patients with acute respiratory infection, tympanitis, sinusitis, or acute asthma attack within 2 weeks before screening. * 4. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications. * 5. Other antiviral therapy is required during screening.
Where this trial is running
Beijing, Beijing
- Beijing Children's Hospital,Capital Medical University — Beijing, Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.