Efficacy and Safety of ZSP1273 in Children 2-11 Years Old With Influenza A

NCT07229807 — Phase 3, Active not recruiting, 119 participants, Guangdong Raynovent Biotech Co., Ltd

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A Phase 3 Study of ZSP1273 in Otherwise Healthy Children 2-11 Years Old With Influenza A

RegistryNCT07229807
StatusActive not recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment119 (Estimated)
SponsorGuangdong Raynovent Biotech Co., Ltd (Industry)
ConditionsInfluenza a
InterventionsZSP1273, Oseltamivir (Drug)
Datesstart 2025-11-22, primary completion 2025-12-17 (estimated), completion 2025-12-31 (estimated), first posted 2025-11-17, last updated 2025-12-16
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Influenza a All trials of ZSP1273 All trials of Oseltamivir

-Summary

This trial is conducted in China. The aim of the trial is to investigate safety and efficacy of ZSP1273 granules

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+Arms and interventions

ArmTypeInterventionsDescription
ZSP1273ExperimentalDrug: ZSP1273
OseltamivirActive comparatorDrug: Oseltamivir
  • ZSP1273 (Drug): Oral
  • Oseltamivir (Drug): Oral

+Outcome measures

Primary outcomes

  • Time to Alleviation of Symptoms [DAY1~DAY15]: Participants assessed the severity of influenza-associated symptoms

Secondary outcomes

  • Plasma concentrations of ZSP1273 [DAY1~5]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [DAY1~15]

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Beijing Children HospitalBeijingChina