NCT06507813

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza Type A
• Influenza Type B

Interventions

Type	Name	Description
DRUG	ADC189 tablets	Patients weigh between 20 to 80 kilograms, given 45 mg ADC189 tablets once; patients weigh over 80 kilograms, given 90 mg ADC189 tablets once.
DRUG	Baloxavir Marboxil tablets	Patients weigh between 20 to 80 kilograms, given 40 mg Baloxavir marboxil tablets once. Patients weigh over 80 kilograms, given 80 mg Baloxavir marboxil tablets once.
DRUG	Placebo of ADC189 tablets	Patients weigh between 20 to 80 kilograms, given 1 tablet of placebo once; patients weigh over 80 kilograms, given 2 tablets of placebo once.
DRUG	Placebo of Baloxavir Marboxil tablets	Patients weigh between 20 to 80 kilograms, given 2 tablets of placebo once; patients weigh over 80 kilograms, given 4 tablets of placebo once.
DRUG	ADC189 granules	For patient 5-11 years old, patients weigh between 20 to 80 kilograms, given 45 mg ADC189 granules once; patients weigh over 80 kilograms, given 90 mg ADC189 granules once. For patient 2-4 years old, patients \<10kg, given 15mg ADC189 granules once. 10kg \~ \<15kg, given 25mg ADC189 granules once. 15kg \~\<20 kg, given 35mg ADC189 granules once. 20kg \~ \<80kg, given 45mg ADC189 granules once.
DRUG	Placebo of ADC189 granules	Placebo. Given once only.
DRUG	Placebo of Oseltamivir granules	For patients 2-4 years old. Placebo. Given 10 times (5 days, BID).
DRUG	Oseltamivir granules	For patients 2-4 years old. Patients \<15kg, given 30mg×10 times (5 days, BID) Oseltamivir granules. 15kg \~ \<23kg, given 45mg×10 times (5 days, BID) Oseltamivir granules. 23kg \~ \<40kg, given 60mg×10 times (5 days, BID) Oseltamivir granules. ≥40kg, given 75mg×10 times (5 days, BID) Oseltamivir granules.

Timeline

• Start date: 2024-08-19
• Primary completion: 2025-01-27
• Completion: 2025-04-15
• First posted: 2024-07-18
• Last updated: 2025-09-23

Locations

1 site across 1 country: China