Influenza Clinical Trial
Official title:
Randomised, Parallel Dose, Phase 1/2 Safety and Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Naturally Acquired Influenza A or B
This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.
Approximately 48 subjects aged 5-17 years inclusive will be randomised into the study.
Subjects with recent onset of presumptive influenza will have influenza A or B infection
confirm by Rapid Antigen Test.
The study will be conducted on an outpatient basis. The dose is administered in a single
session in the clinic on Day 1. The subject will return to the clinic for assessments and
follow up.
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