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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Influenza a
• Intervention / Treatment: Drug: Oseltamivir; Drug: ZSP1273

• Study Type: Interventional
• Enrollment (Estimated): 119
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Children 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
Experimental: ZSP1273	Drug: ZSP1273; Oral
Active Comparator: Oseltamivir	Drug: Oseltamivir; 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 influenza-associated symptoms	DAY1~DAY15

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations of ZSP1273	DAY1~5
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	DAY1~15

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2025
• Primary Completion (Estimated): December 17, 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: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Amides; Acetamides; Oseltamivir; ZSP1273
• Other Study ID Numbers: ZSP1273-25-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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