Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in China. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ZSP1273 in the treatment of Acute Uncomplicated influenza A in adolescents.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZSP1273 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZSP1273 | Drug | Oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Alleviation of Symptoms | Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). | DAY1~DAY15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | DAY1~DAY15 | |
| Plasma concentrations of ZSP1273 | DAY1~DAY15 |
Not provided
Inclusion Criteria:
Participants and their guardians who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately.
Male or female participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form.
Participants with a diagnosis of influenza virus infection confirmed by all of the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | China |
Not provided
| ID | Term |
|---|---|
| C000721066 | ZSP1273 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral |
|