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

NCT06656026 | Completed Phase 2

• 1 other identifier: ZSP1273-23-17
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of ZSP1273

  DAY1~5

Secondary Outcomes (3)

• 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

Study Arms (2)

ZSP1273(Arm a)

EXPERIMENTAL

* ≥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

ZSP1273(Arm b)

EXPERIMENTAL

* ≥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

Interventions

ZSP1273 granules DRUG

Oral

ZSP1273(Arm a); ZSP1273(Arm b)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 24, 2024
• Study Start: November 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: November 17, 2025

Record last verified: 2024-10

Locations

CN (1)