Influenza A
Conditions
Brief summary
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.
Interventions
DRUGZSP1273
Oral
DRUGPlacebo
Oral
Sponsors
Guangdong Raynovent Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Male or female participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form. 3. Participants with a diagnosis of influenza virus infection confirmed by all of the following: 1. Positive rapid antigen test (RAT) for influenza with nasal or throat swabs; 2. The time interval between the onset of symptoms and enrollment is 48 hours or less; 3. Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present
Exclusion criteria
1. Participants with severe influenza virus infection； 2. Participants with any medical history in gastrointestinal that interferes with the absorption of drugs； 3. Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus \[HIV\] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment； 4. Have received any other investigational products within 3 months prior to dosing； 5. Positive urine pregnancy test； 6. Participants with concurrent infections requiring antimicrobial therapy； 7. Participants who are considered inappropriate for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Alleviation of Symptoms | DAY1~DAY15 | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | DAY1~DAY15 |
| Plasma concentrations of ZSP1273 | DAY1~DAY15 |
Countries
China
Outcome results
None listed