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NCT06656026 | NOT YET RECRUITING | Influenza a

Pharmacokinetics，Safety and Efficacy of ZSP1273 in Children 2-17 Years Old With Influenza A
Sponsor:

Guangdong Raynovent Biotech Co., Ltd

Brief Summary:

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

Condition or disease

Influenza a

Intervention/treatment

ZSP1273 granules

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 72 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : A Open-label Phase 2 Study of ZSP1273 in Otherwise Healthy Children 2-17 Years Old With Influenza A
Actual Study Start Date : 2024-11-30
Estimated Primary Completion Date : 2025-11-30
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 2 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Pharmacokinetics，Safety and Efficacy of ZSP1273 in Children 2-17 Years Old With Influenza A

Location Details

NCT06656026

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Locations

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