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

Phase 3

Recruiting

• Conditions: Influenza Type A; Influenza Type B
• Interventions: Drug: ADC189 tablets; Drug: Baloxavir Marboxil tablets; Drug: Placebo of Baloxavir Marboxil tablets; Drug: Placebo of ADC189 tablets; Drug: ADC189 granules; Drug: Placebo of ADC189 granules; Drug: Placebo of Oseltamivir granules; Drug: Oseltamivir granules

• Registration Number: NCT06507813
• Lead Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-06-28
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ADC189 tablets Group (Part 1)	ADC189 tablets	Around 30 patients, 6-11 years old.
ADC189 tablets Group (Part 1)	Placebo of Baloxavir Marboxil tablets	Around 30 patients, 6-11 years old.
Baloxavir marboxil tablets Group (Part 1)	Baloxavir Marboxil tablets	Around 15 patients, 6-11 years old.
Baloxavir marboxil tablets Group (Part 1)	Placebo of ADC189 tablets	Around 15 patients, 6-11 years old.
ADC189 granules Group (Part 2A)	Placebo of Baloxavir Marboxil tablets	Around 60 patients, 5-11 years old.
ADC189 granules Group (Part 2A)	ADC189 granules	Around 60 patients, 5-11 years old.
Baloxavir marboxil tablets (Part 2A)	Baloxavir Marboxil tablets	Around 30 patients, 5-11 years old.
Baloxavir marboxil tablets (Part 2A)	Placebo of ADC189 granules	Around 30 patients, 5-11 years old.
ADC189 granules (Part 2B)	ADC189 granules	Around 20 patients, 2-4 years old.
ADC189 granules (Part 2B)	Placebo of Oseltamivir granules	Around 20 patients, 2-4 years old.
Oseltamivir granules (Part 2B)	Placebo of ADC189 granules	Around 10 patients, 2-4 years old.
Oseltamivir granules (Part 2B)	Oseltamivir granules	Around 10 patients, 2-4 years old.

Primary Outcome Measures

Name	Time	Method
The safety of study drug, Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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 Outcome Measures

Name	Time	Method
Plasma Concentrations of ADC189 and ADC189-I07	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.
Time to Resolution of Influenza Symptoms	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.

Trial Locations

Locations (1)

Beijing Children's Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China