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

NCT ID: NCT06656026

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-07-31

Brief Summary

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

Conditions

Influenza a

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ZSP1273 granules

Intervention Type: DRUG

Oral

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

Group Type: EXPERIMENTAL

ZSP1273 granules

Intervention Type: DRUG

Oral

Interventions

ZSP1273 granules

Oral

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ZSP1273-23-17

Identifier Type: -

Identifier Source: org_study_id