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

NCT07229820 | Active Not Recruiting Phase 3

• 1 other identifier: ZSP1273-25-21
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza A

Outcome Measures

Primary Outcomes (1)

• Time to Alleviation of Symptoms

  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).

  DAY1~DAY15

Secondary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  DAY1~DAY15

• Plasma concentrations of ZSP1273

  DAY1~DAY15

Study Arms (2)

ZSP1273

EXPERIMENTAL

Drug: ZSP1273

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ZSP1273 DRUG

Oral

ZSP1273

Placebo DRUG

Oral

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Male or female participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form.
• Participants 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 48 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:

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

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Ruijin Hospital

Shanghai, China

Location

MeSH Terms

Interventions

ZSP1273

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 8, 2025
• Primary Completion: December 22, 2025
• Study Completion: December 31, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-10

Locations

CN (1)