A Multicenter, Randomized, Double-blind, Positive Controlled, Phase III Trial to Evaluate the Safety and Efficacy of ZX-7101A for Oral Suspension in Pediatric Participants Aged 2 to 11 With Influenza

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this phase III study is to learn if ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years. The main question it aims to answer is: What medical problems do participants have when taking drug ZX-7101A for oral suspension or Oseltamivir phosphate for oral suspension? Researchers will compare drug ZX-7101A for oral suspension to active comparator: Oseltamivir phosphate for oral suspension to see if drug ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 11
Healthy Volunteers: f
View:

• ≥2 to\<12 years of age at the time of randomization, males or females.

• Patients in the screening period met the following criteria:

‣ Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive;

⁃ Axillary temperature ≥ 37.5℃ at screening; If taking antipyretics, axillary temperature ≥ 37.5℃ after taking the drug (more than 4 hours).

⁃ At least one of the influenza-related respiratory symptoms is moderate or greater in severity: nasal congestion/runny nose and coughing.

• The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization. The occurrence of symptoms is defined as:

‣ The body temperature first reached ≥ 37.5℃ (axillary/oral temperature) or 38.0℃ (rectal or tympanic temperature);

⁃ Or the occurrence of at least one systemic or respiratory symptom: nasal congestion, sore throat, cough, muscle pain, headache, etc.

• The guardian of the participants must agree to participate in the study and sign a written informed consent form. For participants aged 8 years old and above, they must sign the informed consent form voluntarily (for participant under the age of 8, only the informed consent form signed by the guardian is required.); The participant s and/or their guardians agree to comply with all study procedures, including filling out the participant diary cards (the guardians of the subjects may assist in the assessment/filling).

Locations
Other Locations
China
West China Second University Hospital, Sichuan University
RECRUITING
Chengdu
Children's Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Lingling Chen
lingling.chen@zenshine-pharma.com
86-025-58185060
Time Frame
Start Date: 2025-10-13
Estimated Completion Date: 2026-04-15
Participants
Target number of participants: 168
Treatments
Experimental: ZX-7101A for oral suspension
A randomized phase III study with safety as primary endpoint was conducted in children (2-11 years old) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A for oral suspension (specification:10mg per bag)or oseltamivir phosphate for oral suspension (specification:0.36 g).~Preparation of suspension solution ZX-7101A: the specification of the dry suspension is 10 mg per bag. Add 10 ml of warm water for each bag, Mix well and take it all at once as soon as possible. Administer the dosage according to body weight.
Active_comparator: Oseltamivir phosphate for oral suspension
A randomized phase III study with safety as primary endpoint was conducted in children (2-11 years old) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A for oral suspension (specification:10mg per bag)or oseltamivir phosphate for oral suspension (specification:0.36 g).~Administer the medication according to the weight specified in the label.
Related Therapeutic Areas
Sponsors
Leads: Nanjing Zenshine Pharmaceuticals

This content was sourced from clinicaltrials.gov

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