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

PHASE3CompletedINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

August 19, 2024

Primary Completion Date

January 27, 2025

Study Completion Date

April 15, 2025

Conditions
Influenza Type AInfluenza 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.

Trial Locations (1)

Unknown

Beijing Children's Hospital,Capital Medical University, Beijing

All Listed Sponsors
lead

Jiaxing AnDiCon Biotech Co.,Ltd

INDUSTRY

NCT06507813 - Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza | Biotech Hunter | Biotech Hunter