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

AnDiCon Biotech

Status and phase: Completed; Phase 3

Conditions: Influenza Type B; Influenza Type A

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06507813

ADC189GR-20230808

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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190 participants in 6 patient groups

ADC189 tablets Group (Part 1)

Experimental group

Description:

Around 30 patients, 6-11 years old.

Treatment:

Drug: Placebo of Baloxavir Marboxil tablets

Drug: ADC189 tablets

Baloxavir marboxil tablets Group (Part 1)

Active Comparator group

Description:

Around 15 patients, 6-11 years old.

Treatment:

Drug: Placebo of ADC189 tablets

Drug: Baloxavir Marboxil tablets

ADC189 granules Group (Part 2A)

Experimental group

Description:

Around 60 patients, 5-11 years old.

Treatment:

Drug: ADC189 granules

Drug: Placebo of Baloxavir Marboxil tablets

Baloxavir marboxil tablets (Part 2A)

Active Comparator group

Description:

Around 30 patients, 5-11 years old.

Treatment:

Drug: Placebo of ADC189 granules

Drug: Baloxavir Marboxil tablets

ADC189 granules (Part 2B)

Experimental group

Description:

Around 20 patients, 2-4 years old.

Treatment:

Drug: ADC189 granules

Drug: Placebo of Oseltamivir granules

Oseltamivir granules (Part 2B)

Active Comparator group

Description:

Around 10 patients, 2-4 years old.

Treatment:

Drug: Placebo of ADC189 granules

Drug: Oseltamivir granules