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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADC189 tablets Group (Part 1) | Experimental | Around 30 patients, 6-11 years old. |
|
| Baloxavir marboxil tablets Group (Part 1) | Active Comparator | Around 15 patients, 6-11 years old. |
|
| ADC189 granules Group (Part 2A) | Experimental | Around 60 patients, 5-11 years old. |
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| Baloxavir marboxil tablets (Part 2A) | Active Comparator | Around 30 patients, 5-11 years old. |
|
| ADC189 granules (Part 2B) | Experimental | Around 20 patients, 2-4 years old. |
|
| Oseltamivir granules (Part 2B) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 up to 14 days, 4 time points. |
| Time to Resolution of Influenza Symptoms |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital,Capital Medical University | Beijing | Beijing Municipality | China |
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| Active Comparator |
Around 10 patients, 2-4 years old. |
|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Placebo of ADC189 granules | Drug | Placebo. Given once only. |
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| Placebo of Oseltamivir granules | Drug | For patients 2-4 years old. Placebo. Given 10 times (5 days, BID). |
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| 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. |
|
Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a CARIFS Questionare. |
| From Day 1 up to 14 days |
| ID | Term |
|---|---|
| C000628402 | baloxavir |
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