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

NCT07229807 | Active Not Recruiting Phase 3

• 1 other identifier: ZSP1273-25-20
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza a

Outcome Measures

Primary Outcomes (1)

• Time to Alleviation of Symptoms

  Participants assessed the severity of influenza-associated symptoms

  DAY1~DAY15

Secondary Outcomes (2)

• Plasma concentrations of ZSP1273

  DAY1~5

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

  DAY1~15

Study Arms (2)

ZSP1273

EXPERIMENTAL

Drug: ZSP1273

Oseltamivir

ACTIVE COMPARATOR

Drug: Oseltamivir

Interventions

ZSP1273 DRUG

Oral

ZSP1273

Oseltamivir DRUG

Oral

Oseltamivir

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Beijing Children Hospital

Beijing, China

Location

MeSH Terms

Interventions

ZSP1273; Oseltamivir

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 22, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 31, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)