Phase I study to evaluate Laninamivir Octanoate
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate in Adults with Chronic Asthma.
IRAS ID
134863
Contact name
Brian Leaker
Contact email
Sponsor organisation
Biota Scientific Management Pty Ltd.
Eudract number
2013-002320-16
ISRCTN Number
n/a
Research summary
A study to investigate the safety, tolerability and pharmacokinetics of single ascending dose ( 40 mg and 80 mg ) of laninamivir octanoate and its metabolite laninamivir administered by inhalation in adult with mild and moderate asthma.
The study drug, named Laninamivir Octanoate, is a ‘neuraminidase inhibitor’ under development for the treatment of influenza (flu) caused by influenza virus Types A and B in healthy population. This means that the drug potentially works to stop the flu virus from multiplying and causing the patient a worsening of symptoms.
Laninamivir Octanoate has advantages over other treatments for flu as it is long-acting and can be given as a single dose for the use for prevention and treatment of flu. It has already been approved in Japan and given safely to 4.8 million people. It has been studied in 2330 healthy volunteers, children and adults with flu the UK, Japan and Asia.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0236
Date of REC Opinion
29 Aug 2013
REC opinion
Further Information Favourable Opinion