Study to Assess the Safety and Efficacy of ZX-7101A in Children Aged 5-11 Years With Influenza

NCT06669351 | Terminated Phase 3

• 1 other identifier: ZX-7101A-210
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

Brief Summary

A multicenter, randomized, double-blind, positive controlled, phase III trial to evaluate the safety and efficacy of ZX-7101A tablets versus oseltamivir phosphate suspension in children aged ≥5 years and \< 12 years with uncomplicated influenza.

Conditions

Respiratory Viral Infection

Keywords

influenza

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetic parameters of ZX-7101A and its metabolite ZX-7101 in plasma

  Part 1: Time to peak drug concentration (Tmax)

  Part 1: 1~2, 4, 8, 24, 96 ,192, 336 hours post-dose

• Pharmacokinetic parameters of ZX-7101A and its metabolite ZX-7101 in plasma

  Part 1: Peak plasma concentration (Cmax)

  Part 1: 1~2, 4, 8, 24, 96 ,192, 336 hours post-dose

• Pharmacokinetic parameters of ZX-7101A and its metabolite ZX-7101 in plasma

  Part 1: Area under the plasma concentration versus time curve (AUC)

  Part 1: 1~2, 4, 8, 24, 96 ,192, 336 hours post-dose

• Pharmacokinetic parameters of ZX-7101A and its metabolite ZX-7101 in plasma

  Part 1: The terminal elimination half-life (t1/2)

  Part 1: 1~2, 4, 8, 24, 96 ,192, 336 hours post-dose

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  Part 2: The Number of Participants with Treatment-Related Adverse Event will be evalated as the change of vital signs, electrocardiogram, physical examination, and Laboratory test compared with the baseline.

  Part 2: From day1 up to day15

Secondary Outcomes (7)

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  Part 1: From day1 up to day15

• Time (in hours) for relief of 7 all influenza symptoms

  Part 2: Baseline, Day 1 up to Day 15

• Proportion of all subjects with remission of influenza symptoms

  Part 2: Baseline, Day 1 up to Day 15

• Influenza virus RNA clearance time (in hours)

  Part 2: Baseline, Day1, Day2, Day3, Day5, Day9, Day15

• Time for influenza virus titer to become negative

  Part 2: Baseline, Day1, Day2, Day3, Day5, Day9, Day15

Study Arms (3)

Single Arm

EXPERIMENTAL

Part 1: A pilot study of pharmacokinetics, safety, and efficacy was conducted in children (5-11 years old, weight ≥20kg) with uncomplicated influenza. A total of 12 subjects were planned to be enrolled.

Drug: ZX-7101A

Oseltamivir phosphate dry suspension:

ACTIVE COMPARATOR

Part 2: A randomized phase III study with safety as primary endpoint was conducted in children (5-11 years old, body weight ≥20kg) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A (2 tablets，specification：10mg, single dose) or oseltamivir phosphate dry suspension（specification：0.36g）.

Other: Placebo for ZX-7101A tablet; Drug: Oseltamivir phosphate dry suspension

ZX-7101A

EXPERIMENTAL

Part 2: A randomized phase III study with safety as primary endpoint was conducted in children (5-11 years old, body weight ≥20kg) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A (2 tablets，specification：10mg, single dose) or oseltamivir phosphate dry suspension（specification：0.36g）.

Drug: ZX-7101A; Other: Placebo for Oseltamivir phosphate dry suspension:

Interventions

ZX-7101A DRUG

On day1: Take two tablets of ZX-7101A orally once (specification: 10mg/ tablet) with appropriate amount of warm water

Single Arm; ZX-7101A

Placebo for ZX-7101A tablet OTHER

Placebo for ZX-7101A tablet: The appearance and properties of placebo tablets were identical to those of the trial drug ZX-7101A tablets. On Day 1, two placebo for ZX-7101A tablets were taken orally with appropriate warm water.

Oseltamivir phosphate dry suspension:

Oseltamivir phosphate dry suspension DRUG

Drug: Oseltamivir phosphate dry suspension: From Day1 to Day 5 : Oseltamivir phosphate suspension was orally administered twice a day, dose according to the label.

Oseltamivir phosphate dry suspension:

Placebo for Oseltamivir phosphate dry suspension: OTHER

Drug: Placebo for Oseltamivir phosphate dry suspension: From Day1 to Day 5 : Placebo for Oseltamivir phosphate suspension was orally administered twice a day, dose according to the label.

ZX-7101A

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥5 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 influenza -related systemic symptoms is moderate or greater in severity: a. muscle or joint pain, b. fatigue, c. headache, d. fever.
• At least one of the influenza-related respiratory symptoms is moderate or greater in severity: a. nasal congestion, b. sore throat, c. cough.
• \. The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
• Body temperature ≥ 37.5 ℃ (axillary temperature) or 37.5 ℃ (oral temperature) or 38.0 ℃ (rectal or tympanic membrane temperature)for the first time;
• Or at least one systemic or respiratory symptom may occur: a. nasal congestion, b. sore throat, c. cough, d. muscle or joint pain, e. fatigue, f. headache, g. fever.
• \. Both the subject and his/her guardian are volunteer to participate in the study and sign the written informed consent form (ICF), the subject could comply with all the study procedures, complete the subject diary as required (the guardian is allowed to fill in if necessary).

You may not qualify if:

• Patients with severe influenza virus infection requiring inpatient treatment. (Meet any one of the following criteria)
• Severe cases with one of the following conditions：
• Persistent high fever for more than 3 days, accompanied by severe cough, purulent sputum, bloody sputum, or chest pain;
• Fast breathing rate, difficulty breathing, cyanosis of lips;
• Delayed response, drowsiness, restlessness, and other mental changes or seizures;
• Severe vomiting, diarrhea, and dehydration symptoms;
• Concomitant pneumonia;
• Significant exacerbation of existing underlying diseases;
• Other clinical situations that require hospitalization.
• Critical cases with one of the following conditions (Including but not limited to)：
• Respiratory failure;
• Acute necrotizing encephalopathy;
• Shock;
• Multiple organ dysfunction;
• Other serious clinical situations that require monitoring and treatment.

Sponsors & Collaborators

• Nanjing Zenshine Pharmaceuticals: lead

Study Sites (3)

Baoding Hospital of Beijing Children's Hospital, Capital Medical University

Baoding, Hebei, China

Location

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Hanmin Liu, MD

  Children's Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Part 1: A pilot study of pharmacokinetics, safety, and efficacy was conducted in children (5-11 years old, weight ≥20kg) with uncomplicated influenza. A total of 12 subjects were planned to be enrolled. (Pharmacokinetic and safety data from at least 8 children are required.) Part 2: A randomized phase III study with safety as primary endpoint was conducted in children (5-11 years old, body weight ≥20kg) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A or oseltamivir phosphate. Enrolled subjects were required to have typical systemic and/or respiratory influenza symptoms, with first influenza symptoms occurring within 48 hours of randomization. A total of 168 subjects were planned to be enrolled.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: October 31, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)