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Study to Assess the Prophylactic Efficacy and Safety of Sebaloxavir Marboxil Tablets/Oral Suspension for Influenza Prevention in Household Contacts Aged ≥2 Years.

NCT07730346 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 858

Last updated 2026-07-28

No results posted yet for this study

Summary

This study is a randomized, double-blind, placebo-controlled phase III clinical trial. The trial participants include index participants (IP) and household contacts (HHC). A total of 536 index participants (the first person in the household diagnosed with influenza) and 858 household contacts (family members living with the index participant) are planned to be enrolled. After the index participants and their household contacts have signed informed consent form and passed screening eligibility, randomization will be performed at the household level in a 1:1 ratio, stratifying by the time from onset of the index participant's initial influenza symptoms to signing of informed consent form (\<24 hours, ≥24 hours), index participant's viral subtype (influenza A, influenza B), and household contact's age (\<12 years, ≥12 years). Household contacts will be assigned to either the Sebaloxavir marboxil group or the placebo group. The study objective is to compare the prophylactic efficacy and safety of Sebaloxavir marboxil tablets/oral suspension versus placebo in household contacts (HHCs).

Conditions

  • Influenza Prevention

Interventions

DRUG

Sebaloxavir marboxil

Dosing Regimen for Household Contacts: Sebaloxavir marboxil tablets/oral suspension is administered based on age as follows: * 18 years: Single dose, Sebaloxavir marboxil tablets: 2 tablets; * 12 years and \<18 years: Single dose, Sebaloxavir marboxil tablets: 1 tablet; * 2 years and \<12 years: Single dose, Sebaloxavir marboxil oral suspension, administered according to body weight.

DRUG

Placebo

Dosing Regimen for Household Contacts: Household contacts will receive the placebo of Sebaloxavir marboxil tablets/oral suspension based on age as follows: * 18 years: Single dose, placebo of Sebaloxavir marboxil tablets: 2 tablets; * 12 years and \<18 years: Single dose, placebo of Sebaloxavir marboxil tablets: 1 tablet; * 2 years and \<12 years: Single dose, placebo of Sebaloxavir marboxil oral suspension, administered according to body weight.

Sponsors & Collaborators

  • Nanjing Zenshine Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-11-07
Primary Completion
2027-12-31
Completion
2028-01-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07730346 on ClinicalTrials.gov