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

Guangdong Raynovent Biotech

Status and phase: Active, not recruiting; Phase 3

Conditions: Influenza A

Treatments: Drug: Placebo; Drug: ZSP1273

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229820

ZSP1273-25-21

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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157 participants in 2 patient groups, including a placebo group

ZSP1273

Experimental group

Treatment:

Drug: ZSP1273

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo