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

NCT ID: NCT06669351

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-07-15

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.

Detailed Description

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.) On the first day, ZX-7101A 20 mg tablets, 2 tablets (specification: 10 mg/ tablet) were taken orally. PK samples were collected before and after the first (D1) dose: 1 to 2 h, 4 h, 8 h, 24 h (D2), 96 h (D5), 192 h (D9) and 336 h (D15) after administration.

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. The study was divided into a screening/treatment period (D1) and an observation period (approximately 2 weeks).

Conditions

Respiratory Viral Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Single Arm

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.

Group Type: EXPERIMENTAL

ZX-7101A

Intervention Type: DRUG

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

Oseltamivir phosphate dry suspension:

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）.

Group Type: ACTIVE_COMPARATOR

Placebo for ZX-7101A tablet

Intervention Type: 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

Intervention Type: 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.

ZX-7101A

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）.

Group Type: EXPERIMENTAL

ZX-7101A

Intervention Type: DRUG

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

Placebo for Oseltamivir phosphate dry suspension:

Intervention Type: 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.

Interventions

ZX-7101A

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

Intervention Type: DRUG

Placebo for ZX-7101A tablet

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.

Intervention Type: OTHER

Oseltamivir phosphate dry suspension

Drug: Oseltamivir phosphate dry suspension:

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

Intervention Type: DRUG

Placebo for Oseltamivir phosphate dry suspension:

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1.≥5 to<12 years of age at the time of randomization, males or females.
• 2.Patients in the screening period met the following criteria:

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

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

3. 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.

4. At least one of the influenza-related respiratory symptoms is moderate or greater in severity: a. nasal congestion, b. sore throat, c. cough.

• 3. The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.

1. Body temperature ≥ 37.5 ℃ (axillary temperature) or 37.5 ℃ (oral temperature) or 38.0 ℃ (rectal or tympanic membrane temperature)for the first time;

2. 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.

• 4. 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).

Exclusion Criteria

• Patients with severe influenza virus infection requiring inpatient treatment. (Meet any one of the following criteria)

1. 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.

2. 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.
• 2. High risk population for severe cases. (Meet any one of the following criteria):

1. Accompanied by the following basic diseases and judged by the investigators to be clinically significant, such as lung diseases, liver diseases, kidney diseases, hematological system diseases, heart diseases, neurological and neuromuscular diseases that affect the ability to clear respiratory secretions, metabolic and endocrine system diseases, etc;

2. Subjects with low immune function, such as malignant tumors, organ or bone marrow transplants, HIV infections, or those who have been taking immunosuppressants for the past 3 months;

3. Clinical significance of correcting QT interval abnormalities in electrocardiogram display; (QTc>440ms in male or QTc>450ms in female);

4. Subjects who require long-term use of drugs containing aspirin or salicylates : It is necessary to take medication containing aspirin or salicylate regularly every day for more than 14 days;

5. BMI exceeds the standards.

• 3. Bronchitis, pneumonia, pleural effusion or interstitial disease confirmed by chest imaging [X-ray (anteroposterior or anteroposterior) /CT] and judged clinically significant by the investigator at screening.
• 4. Subjects who have developed acute respiratory tract infection, otitis media, and sinusitis within 2 weeks before screening.
• 5. Subjects with other respiratory infections requiring systemic anti-infective treatment, or blood routine examination at screening: white blood cell count (WBC) > (venous blood)
• 6. Subjects with purulent sputum or suppurative tonsillitis.
• 7. Have difficulty in swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, subtotal gastrectomy, etc.).
• 8. Suspected allergic to active ingredients or excipients of the investigational product.
• 9. Body weight < 20 kg.
• 10. Medications against influenza virus within 7 days before screening (including but not limited to: neuraminidase inhibitors, hemagglutinin inhibitors, M2 ion channel blockers, and cap structure inhibitors. Lysine endonuclease (CEN) inhibitors, such as oseltamivir, zanamivir, peramivir, favipiravir, rimantadine, amantadine, abidol, baloxavir, etc.).
• 11. Have received live vaccines or attenuated live vaccines within 14 days before randomization, influenza vaccines within 6 months before randomization.
• 12. Suspected or confirmed a history of alcohol or drug abuse.
• 13. Ppregnancy test was positive
• 14. Participants who participated in another clinical trial and used any other investigational drug or device within 30 days before screening.
• 15. Subjects judged by the investigator to be ineligible for participation in the study.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Zenshine Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanmin Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, Zhejiang University School of Medicine

Locations

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

Baoding, Hebei, China

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ZX-7101A-210

Identifier Type: -

Identifier Source: org_study_id