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

Phase 2

Recruiting

• Conditions: Influenza a
• Interventions: Drug: ZSP1273 granules

• Registration Number: NCT06656026
• Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-24
• Study Start: 2024-11-30
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZSP1273(Arm a)	ZSP1273 granules	* ≥2 ，\<6 year old，dose 1 QD；5day * ≥6 ，\<12 year old，dose 2 QD；5day * ≥12，≤17 year old，dose 3 QD；5day
ZSP1273(Arm b)	ZSP1273 granules	* ≥2 ，\<6 year old，dose 4 QD；5day * ≥6 ，\<12 year old，dose 5 QD；5day * ≥12，≤17 year old，dose 6 QD；5day

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of ZSP1273	DAY1~5

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The First Affiliated Hospital Of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China