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

NCT06507813 | Completed Phase 3

• 1 other identifier: ADC189GR-20230808
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The safety of study drug, Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

  From Day 1 up to 15 days

Secondary Outcomes (2)

• Plasma Concentrations of ADC189 and ADC189-I07

  From Day 1 up to 14 days, 4 time points.

• Time to Resolution of Influenza Symptoms

  From Day 1 up to 14 days

Study Arms (6)

ADC189 tablets Group (Part 1)

EXPERIMENTAL

Around 30 patients, 6-11 years old.

Drug: ADC189 tablets; Drug: Placebo of Baloxavir Marboxil tablets

Baloxavir marboxil tablets Group (Part 1)

ACTIVE COMPARATOR

Around 15 patients, 6-11 years old.

Drug: Baloxavir Marboxil tablets; Drug: Placebo of ADC189 tablets

ADC189 granules Group (Part 2A)

EXPERIMENTAL

Around 60 patients, 5-11 years old.

Drug: Placebo of Baloxavir Marboxil tablets; Drug: ADC189 granules

Baloxavir marboxil tablets (Part 2A)

ACTIVE COMPARATOR

Around 30 patients, 5-11 years old.

Drug: Baloxavir Marboxil tablets; Drug: Placebo of ADC189 granules

ADC189 granules (Part 2B)

EXPERIMENTAL

Around 20 patients, 2-4 years old.

Drug: ADC189 granules; Drug: Placebo of Oseltamivir granules

Oseltamivir granules (Part 2B)

ACTIVE COMPARATOR

Around 10 patients, 2-4 years old.

Drug: Placebo of ADC189 granules; Drug: Oseltamivir granules

Interventions

Placebo of Oseltamivir granules DRUG

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

ADC189 granules (Part 2B)

ADC189 tablets 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.

ADC189 tablets Group (Part 1)

Baloxavir Marboxil tablets 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.

Baloxavir marboxil tablets (Part 2A); Baloxavir marboxil tablets Group (Part 1)

Placebo of ADC189 tablets 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.

Baloxavir marboxil tablets Group (Part 1)

Placebo of Baloxavir Marboxil tablets 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 Group (Part 2A); ADC189 tablets Group (Part 1)

ADC189 granules 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.

ADC189 granules (Part 2B); ADC189 granules Group (Part 2A)

Placebo of ADC189 granules DRUG

Placebo. Given once only.

Baloxavir marboxil tablets (Part 2A); Oseltamivir granules (Part 2B)

Oseltamivir granules 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.

Oseltamivir granules (Part 2B)

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiaxing AnDiCon Biotech Co.,Ltd: lead

Study Sites (1)

Beijing Children's Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

baloxavir

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: August 19, 2024
• Primary Completion: January 27, 2025
• Study Completion: April 15, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)