drugset / Trial / NCT06774859
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety of a single dose baloxavir marboxil compared with 5 days of oseltamivir administered twice a day (BID) in Chinese pediatric participants aged 1 to \< 12 years with influenza symptoms.
Timeline
- Start
- 2024-10-27
- Primary completion
- 2025-05-08
- Completion
- 2025-05-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baloxavir Marboxil | Unknown | 2 mg/kg | Oral |
| Subject | Baloxavir Marboxil | Unknown | 40 mg | Oral |
| Subject | Baloxavir Marboxil | Unknown | 80 mg | Oral |
| Comparator | Oseltamivir | Small molecule | 30 mg | Oral |
| Comparator | Oseltamivir | Small molecule | 45 mg | Oral |
| Comparator | Oseltamivir | Small molecule | 60 mg | Oral |
| Comparator | Oseltamivir | Small molecule | 75 mg | Oral |