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

NCT ID: NCT06507813

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2025-04-15

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.

Conditions

Influenza Type A; Influenza Type B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ADC189 tablets Group (Part 1)

Around 30 patients, 6-11 years old.

Group Type: EXPERIMENTAL

ADC189 tablets

Intervention Type: DRUG

Patients weigh between 20 to 80 kilograms, given 45 mg ADC189 tablets once; patients weigh over 80 kilograms, given 90 mg ADC189 tablets once.

Placebo of Baloxavir Marboxil tablets

Intervention Type: DRUG

Patients weigh between 20 to 80 kilograms, given 2 tablets of placebo once; patients weigh over 80 kilograms, given 4 tablets of placebo once.

Baloxavir marboxil tablets Group (Part 1)

Around 15 patients, 6-11 years old.

Group Type: ACTIVE_COMPARATOR

Baloxavir Marboxil tablets

Intervention Type: DRUG

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.

Placebo of ADC189 tablets

Intervention Type: DRUG

Patients weigh between 20 to 80 kilograms, given 1 tablet of placebo once; patients weigh over 80 kilograms, given 2 tablets of placebo once.

ADC189 granules Group (Part 2A)

Around 60 patients, 5-11 years old.

Group Type: EXPERIMENTAL

Placebo of Baloxavir Marboxil tablets

Intervention Type: DRUG

Patients weigh between 20 to 80 kilograms, given 2 tablets of placebo once; patients weigh over 80 kilograms, given 4 tablets of placebo once.

ADC189 granules

Intervention Type: DRUG

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.

Baloxavir marboxil tablets (Part 2A)

Around 30 patients, 5-11 years old.

Group Type: ACTIVE_COMPARATOR

Baloxavir Marboxil tablets

Intervention Type: DRUG

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.

Placebo of ADC189 granules

Intervention Type: DRUG

Placebo. Given once only.

ADC189 granules (Part 2B)

Around 20 patients, 2-4 years old.

Group Type: EXPERIMENTAL

ADC189 granules

Intervention Type: DRUG

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.

Placebo of Oseltamivir granules

Intervention Type: DRUG

For patients 2-4 years old. Placebo. Given 10 times (5 days, BID).

Oseltamivir granules (Part 2B)

Around 10 patients, 2-4 years old.

Group Type: ACTIVE_COMPARATOR

Placebo of ADC189 granules

Intervention Type: DRUG

Placebo. Given once only.

Oseltamivir granules

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo of ADC189 granules

Placebo. Given once only.

Intervention Type: DRUG

Placebo of Oseltamivir granules

For patients 2-4 years old. Placebo. Given 10 times (5 days, BID).

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Patients aged 2 to 11 years at screening, both sex;
• 2. Patients were diagnosed with Influenza A Vairus Infection/Influenza B Virus Infection.
• 3. Parents willing and able to comply with study requirements, under the judgment of investigators .
• 4. Onset of symptoms no more than 48 hours before presentation for screening.

Exclusion Criteria

• 1. Patients with severe influenza.
• 2. Pregnant or breast-feeding females
• 3. Patients with acute respiratory infection, tympanitis, sinusitis, or acute asthma attack within 2 weeks before screening.
• 4. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications.
• 5. Other antiviral therapy is required during screening.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiaxing AnDiCon Biotech Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Children's Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ADC189GR-20230808

Identifier Type: -

Identifier Source: org_study_id