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Active, not recruiting Phase 3

Efficacy and Safety of ZSP1273 in Children 12-17 Years Old With Influenza A

NCT07229820 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-11-08
Last updated
2025-12-16

Condition(s) studied

Influenza A

Investigational drug(s) / intervention(s)

ZSP1273Placebo

ZSP1273: Oral

Placebo: Oral

Study summary

This trial is conducted in China. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ZSP1273 in the treatment of Acute Uncomplicated influenza A in adolescents.

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participants 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 participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form. 3. Participants with a diagnosis of influenza virus infection confirmed by all of the following: 1. Positive rapid antigen test (RAT) for influenza with nasal or throat swabs; 2. The time interval between the onset of symptoms and enrollment is 48 hours or less; 3. Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present Exclusion Criteria: 1. Participants with severe influenza virus infection; 2. Participants 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. Participants with concurrent infections requiring antimicrobial therapy; 7. Participants who are considered inappropriate for the study by the investigator.

Primary outcome measure(s)

  • Time to Alleviation of Symptoms — DAY1~DAY15
    Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital Shanghai China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07229820 on ClinicalTrials.gov ↗ ← All trials in China