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

A Open-label Phase 2 Study of ZSP1273 in Otherwise Healthy 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

Study Overview

• Status: Completed
• Conditions: Influenza a
• Intervention / Treatment: Drug: ZSP1273 granules

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 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.
2. Male or female subjects aged ≥ 2 to ≤17 years at the time of signing the informed consent form.

3. 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:

1. Subjects with severe influenza virus infection；
2. Subjects 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. Subjects with concurrent infections requiring antimicrobial therapy；
7. Subjects who are considered inappropriate for the study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZSP1273(Arm a); ≥2 ，<6 year old，dose 1 QD；5day; ≥6 ，<12 year old，dose 2 QD；5day; ≥12，≤17 year old，dose 3 QD；5day	Drug: ZSP1273 granules; Oral
Experimental: ZSP1273(Arm b); ≥2 ，<6 year old，dose 4 QD；5day; ≥6 ，<12 year old，dose 5 QD；5day; ≥12，≤17 year old，dose 6 QD；5day	Drug: ZSP1273 granules; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations of ZSP1273	DAY1~5

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	DAY1~29
Time to alleviation of influenza symptoms (duration of influenza)	DAY1~29
Percentage of subjects with virus titer detected	DAY1~29

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: ZSP1273-23-17

Drug and device information, study documents

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