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NCT Number: NCT07229820

Efficacy and Safety of ZSP1273 in Children 12-17 Years Old With Influenza A

This trial is conducted in China. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ZSP1273 in the treatment of Acute Uncomplicated influenza A in adolescents.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ruijin Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.
  • Male or female participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form.
  • Participants 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 48 hours or less;
  • Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present

Exclusion criteria

  • Participants with severe influenza virus infection;
  • Participants 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;
  • Participants with concurrent infections requiring antimicrobial therapy;
  • Participants who are considered inappropriate for the study by the investigator.

Treatment and study plan

ZSP1273

Drug

Oral

Placebo

Drug

Oral

Primary outcomes

  1. Time to Alleviation of Symptoms

    Time frame: DAY1~DAY15

    Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).

Secondary outcomes

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

    Time frame: DAY1~DAY15

  2. Plasma concentrations of ZSP1273

    Time frame: DAY1~DAY15

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo in Children 12-17 Years Old With Acute Uncomplicated Influenza A

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
Dec 16, 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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