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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
190
Patients weigh between 20 to 80 kilograms, given 45 mg ADC189 tablets once; patients weigh over 80 kilograms, given 90 mg ADC189 tablets once.
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.
Patients weigh between 20 to 80 kilograms, given 1 tablet of placebo once; patients weigh over 80 kilograms, given 2 tablets of placebo once.
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality, China
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.
Time frame: From Day 1 up to 15 days
Plasma Concentrations of ADC189 and ADC189-I07
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 frame: From Day 1 up to 14 days, 4 time points.
Time to Resolution of Influenza Symptoms
Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a CARIFS Questionare.
Time frame: From Day 1 up to 14 days
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Patients weigh between 20 to 80 kilograms, given 2 tablets of placebo once; patients weigh over 80 kilograms, given 4 tablets of placebo once.
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. Given once only.
For patients 2-4 years old. Placebo. Given 10 times (5 days, BID).
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.