A Phase 3 Study of ZSP1273 in Otherwise Healthy Children 2-11 Years Old With Influenza A
| Registry | NCT07229807 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 119 (Estimated) |
| Sponsor | Guangdong Raynovent Biotech Co., Ltd (Industry) |
| Conditions | Influenza a |
| Interventions | ZSP1273, Oseltamivir (Drug) |
| Dates | start 2025-11-22, primary completion 2025-12-17 (estimated), completion 2025-12-31 (estimated), first posted 2025-11-17, last updated 2025-12-16 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Influenza a All trials of ZSP1273 All trials of Oseltamivir
This trial is conducted in China. The aim of the trial is to investigate safety and efficacy of ZSP1273 granules
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ZSP1273 | Experimental | Drug: ZSP1273 | |
| Oseltamivir | Active comparator | Drug: Oseltamivir |
Sex: All, ages: 2 Years to 11 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing Children Hospital | Beijing | China |