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

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

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.

Sponsors & Collaborators

• Jiaxing AnDiCon Biotech Co.,Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

2 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-19

Primary Completion

2025-01-27

Completion

2025-04-15

Countries

• China

Study Locations