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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Influenza A
• Intervention / Treatment: Drug: Placebo; Drug: ZSP1273

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral
Experimental: ZSP1273	Drug: ZSP1273; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Alleviation of Symptoms	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).	DAY1~DAY15

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	DAY1~DAY15
Plasma concentrations of ZSP1273	DAY1~DAY15

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2025
• Primary Completion (Estimated): December 22, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: ZSP1273
• Other Study ID Numbers: ZSP1273-25-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No