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Completed

NCT Number: NCT06656026

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

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

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Key information

Conditions

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Male or female subjects aged ≥ 2 to ≤17 years at the time of signing the informed consent form.
  • 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

  • Subjects with severe influenza virus infection;
  • Subjects with any medical history in gastrointestinal that interferes with the absorption of drugs;
  • Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus [HIV] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment;
  • Have received any other investigational products within 3 months prior to dosing;
  • Positive urine pregnancy test;
  • Subjects with concurrent infections requiring antimicrobial therapy;
  • Subjects who are considered inappropriate for the study by the investigator.

Treatment and study plan

zsp1273 granules

Drug

Oral

Primary outcomes

  1. Plasma concentrations of ZSP1273

    Time frame: DAY1~5

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: DAY1~29

  2. Time to alleviation of influenza symptoms (duration of influenza)

    Time frame: DAY1~29

  3. Percentage of subjects with virus titer detected

    Time frame: DAY1~29

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

A Open-label Phase 2 Study of ZSP1273 in Otherwise Healthy Children 2-17 Years Old With Influenza A

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2024
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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