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drugset / Trial / NCT06507813

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

NCT06507813 ↗

Phase 3 Completed 190 enrolled Jiaxing AnDiCon Biotech Co.,Ltd
RandomizedSequentialTriple-blindTreatment

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.

Timeline

Start
2024-08-19
Primary completion
2025-01-27
Completion
2025-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject ADC189 granules Unknown 15 mg Oral
Subject ADC189 granules Unknown 25 mg Oral
Subject ADC189 granules Unknown 35 mg Oral
Subject ADC189 granules Unknown 45 mg Oral
Subject ADC189 granules Unknown 90 mg Oral
Subject ADC189 tablets Unknown 45 mg Oral
Subject ADC189 tablets Unknown 90 mg Oral
Comparator Baloxavir Marboxil tablets Unknown 40 mg Oral
Comparator Baloxavir Marboxil tablets Unknown 80 mg Oral
Comparator Oseltamivir granules Unknown 30 mg —
Comparator Oseltamivir granules Unknown 45 mg —
Comparator Oseltamivir granules Unknown 60 mg —
Comparator Oseltamivir granules Unknown 75 mg —

Indications

influenza