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

Guangdong Raynovent Biotech

Status and phase: Completed; Phase 2

Conditions: Influenza a

Treatments: Drug: ZSP1273 granules

Study type: Interventional

Funder types: Industry

Identifiers

NCT06656026

ZSP1273-23-17

Details and patient eligibility

About

This trial is conducted in China. The aim of the trial is to investigate safety,pharmacokinetics and pharmacodynamics of ZSP1273 granules

Enrollment: 72 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

ZSP1273(Arm a)

Experimental group

Description:

* ≥2 ，\<6 year old，dose 1 QD；5day * ≥6 ，\<12 year old，dose 2 QD；5day * ≥12，≤17 year old，dose 3 QD；5day

Treatment:

Drug: ZSP1273 granules

ZSP1273(Arm b)

Experimental group

Description:

* ≥2 ，\<6 year old，dose 4 QD；5day * ≥6 ，\<12 year old，dose 5 QD；5day * ≥12，≤17 year old，dose 6 QD；5day

Treatment:

Drug: ZSP1273 granules