NCT07113392

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

A Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Suraxavir Marboxil for Suspension in Pediatric Patients (2 to <12 Years) With Uncomplicated Influenza

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Suraxavir Marboxil	Suraxavir Marboxil will be administered as oral suspension: 40 mg (if weight ≥ 32 kg), or 20 mg (if weight \<32 kg).
DRUG	Oseltamivir	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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-08-08
• Last updated: 2025-08-08