AIT02-2001 Safety and Protective Efficacy Study of FF-3 Dry Powder
Research type
Research Study
Full title
A Phase 2a, Randomized, Double-blind, Placebo-controlled Assessment of the Safety and Protective Efficacy of FF-3 Dry Powder Administered by Nasal Inhalation for 5 Days to Healthy Adult Subjects who are Experimentally Infected with a Challenge Strain of Influenza A Virus
IRAS ID
179750
Contact name
Tim Mant
Contact email
Sponsor organisation
Autoimmune Technologies, LLC
Eudract number
2015-001103-31
Duration of Study in the UK
0 years, 6 months, 16 days
Research summary
This study is conducted in order to determine if a new drug called FF-3 can protect healthy volunteers against infection with a strain of Influenza A which can cause "flu". The study will include 75 healthy volunteers. 50 of them will receive FF-3 and 25 will receive placebo (dummy medication). FF-3 will be administered through nasal inhalation.The effect of FF-3 will be evaluated by measuring the concentration of the virus in samples taken from the nose and also by the symptoms of flu developed by the volunteers. The study will also investigate the safety of FF-3 when administered through nasal inhalation. All volunteers that are selected for the study will be confined in the research unit for a period of at least 12 days. They will be discharged when considered well and non-infectious. Based on previous data it is expected that discharge will be after 12 days confinement.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0218
Date of REC Opinion
16 Jun 2015
REC opinion
Further Information Favourable Opinion