Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza

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

Currently, there is only one treatment which only need one single oral dose for influenza in children five years above (Baloxavir marboxil) in China. This study will test a medicine for influenza in children younger than 5 year of age to see if it is safe and effective.

This is a multicenter, randomized, double-blind, controlled Phase III clinical study.

The study evaluates the pharmacokinetics, safety and efficacy of ADC189 tablets/granules following a single oral dose in children aged 2 to 11 years with influenza.

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.