Influenza a
Conditions
Brief summary
This trial is conducted in China. The aim of the trial is to investigate safety,pharmacokinetics and pharmacodynamics of ZSP1273 granules
Interventions
DRUGZSP1273 granules
Oral
Sponsors
Guangdong Raynovent Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects 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 subjects aged ≥ 2 to ≤17 years at the time of signing the informed consent form. 3. Subjects with a diagnosis of influenza virus infection confirmed by all of the following: * Positive rapid antigen test (RAT) for influenza with nasal or throat swabs; * The time interval between the onset of symptoms and enrollment is 72 hours or less; * Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present
Exclusion criteria
1. Subjects with severe influenza virus infection； 2. Subjects 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. Subjects with concurrent infections requiring antimicrobial therapy； 7. Subjects who are considered inappropriate for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of ZSP1273 | DAY1~5 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | DAY1~29 |
| Time to alleviation of influenza symptoms (duration of influenza) | DAY1~29 |
| Percentage of subjects with virus titer detected | DAY1~29 |
Countries
China
Outcome results
None listed