Skip to main content
OpenTrials
Completed

NCT Number: NCT06507813

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza Type A Influenza Type B

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Children's Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Key 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.

Treatment and study plan

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.

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.

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.

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

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 ADC189 granules

Drug

Placebo. Given once only.

Placebo of Oseltamivir granules

Drug

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

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.

Primary outcomes

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

    Time frame: From Day 1 up to 15 days

    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.

Secondary outcomes

  1. Plasma Concentrations of ADC189 and ADC189-I07

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

    ADC189-I07 is an active metabolite of ADC189. Four plasma samples were collected in 4 time points from each patient. This data is collected for Pop PK analysis.

  2. Time to Resolution of Influenza Symptoms

    Time frame: From Day 1 up to 14 days

    Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a CARIFS Questionare.

Sponsors and collaborators

Lead sponsor

Jiaxing AnDiCon Biotech Co.,Ltd

Industry

Registry information

Official study title

A Phase III, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate Pharmacokinetics, Safety and Efficacy of ADC189 Tablets/Granules in Children 2-11 Years Old With Influenza

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.