clinical trial · NCT06507813
Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza
Jiaxing AnDiCon Biotech Co.,Ltd·phase3·completed·n = 190
Influenza Type AInfluenza Type BADC189 tabletsBaloxavir Marboxil tabletsPlacebo of ADC189 tabletsPlacebo of Baloxavir Marboxil tabletsADC189 granulesPlacebo of ADC189 granulesPlacebo of Oseltamivir granulesOseltamivir granules
brief summary
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.
started
Aug 19, 2024
primary completion
Jan 27, 2025
completion
Apr 15, 2025
last updated
Sep 23, 2025
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol