Investigating ZSP1273 for treating Influenza A in children

A Open-label Phase 2 Study of ZSP1273 in Otherwise Healthy Children 2-17 Years Old With Influenza A

This study is testing a new medication called ZSP1273 to see if it helps children aged 2 to 17 with Influenza A feel better and how their bodies handle the drug.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: Guangdong Raynovent Biotech Co., Ltd (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06656026 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the safety, pharmacokinetics, and pharmacodynamics of ZSP1273 granules in children aged 2 to 17 years diagnosed with Influenza A. Conducted in China, the study will enroll participants who have confirmed influenza infections and will monitor their responses to the treatment. The trial will assess how the drug is absorbed and processed in the body, as well as its overall effectiveness in alleviating symptoms of the virus.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 17 years with a confirmed diagnosis of Influenza A and presenting specific symptoms.

Not a fit: Patients with severe influenza infections or gastrointestinal issues that affect drug absorption may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing Influenza A in children.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating new antiviral treatments for influenza.

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.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital Of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xu, Doctor

Conditions Influenza a