Influenza Type A, Influenza Type B
Conditions
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.
Interventions
DRUGADC189 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.
DRUGBaloxavir 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.
DRUGPlacebo 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.
DRUGPlacebo 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.
DRUGADC189 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.
DRUGPlacebo of ADC189 granules
Placebo. Given once only.
DRUGPlacebo of Oseltamivir granules
For patients 2-4 years old. Placebo. Given 10 times (5 days, BID).
DRUGOseltamivir 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.
Sponsors
Jiaxing AnDiCon Biotech Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed