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The goal of this phase III study is to learn if JKN2301 Dry Suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JKN2301 + Oseltamivir Placebo | Experimental |
| |
| Oseltamivir + JKN2301 Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JKN2301 Dry Suspension | Drug | Single oral dose, administered according to a weight-tiered dosing scheme. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs) | Baseline through Day 15 | |
| Clinically significant changes in laboratory parameters, vital signs, physical examination, and ECG | Baseline through Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration-time profiles of JKN2301 and its relevant metabolites | At multiple timepoints up to Day 6 | |
| Time to alleviation of all influenza symptoms | From treatment initiation up to Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Yang | Contact | +86-0755-33268688 | overseas@joincare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Oseltamivir Placebo | Drug | Oral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir. |
|
| Oseltamivir | Drug | Oral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen. |
|
| JKN2301 Placebo | Drug | Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301. |
|
| Duration of fever | From treatment initiation up to Day 15 |
| Time to cessation of viral shedding assessed by viral culture | From treatment initiation up to Day 9 |
| Change from baseline in viral titer | Baseline to Day 9 |
| Incidence of influenza-related complications | Up to Day 15 |
| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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