A Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Suraxavir Marboxil for Suspension

Sponsor
Jiangxi Kvvit Pharmaceutical Co., Ltd.
Study ID
NCT07113392
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
2 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Suraxavir Marboxil — DRUG
    Suraxavir Marboxil will be administered as oral suspension: 40 mg (if weight ≥ 32 kg), or 20 mg (if weight \<32 kg).
  • Oseltamivir — DRUG
    Oseltamivir will be administered as oral granules: 30 mg (if weight ≤15 kg), 45 mg (if weight \> 15 kg to ≤ 23 kg), 60 mg (if weight \> 23 kg to ≤ 40 kg) or 75 mg (if weight \> 40 kg), twice daily (BID) for 5 days.

Study Details

This study will evaluate the safety, efficacy and pharmacokinetics of Suraxavir Marboxil compared with oseltamivir in Pediatric Patients (2 to \<12 Years) with Uncomplicated Influenza.

Key Dates

First listed
Aug 8, 2025
Start date
Aug 1, 2025
Status verified
Aug 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Suraxavir Marboxil
    Participants will receive a single oral dose of Suraxavir Marboxil on Day 1 based on body weight.
  • Active Comparator: Oseltamivir
    Participants will receive oseltamivir twice a day for 5 days based on body weight.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: up to Day 15 ]

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