Phase 2 study of MHAA4549A for seasonal Influenza A infection
Research type
Research Study
Full title
A Phase 2 a randomized, double-blind, placebo-controlled trial of MHAA4549A, a monoclonal antibody, administered as monotherapy for the treatment of acute uncomplicated seasonal influenza A infection in otherwise healthy adults
IRAS ID
206679
Contact name
Manish Saxena
Contact email
Sponsor organisation
Genentech Inc.
Eudract number
2016-000425-40
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
117318, IND number
Duration of Study in the UK
1 years, 1 months, 24 days
Research summary
Influenza is a respiratory illness which typically results in mild symptoms, such as fever and cough, from which most people recover without requiring medical attention. However, it can also cause serious complications requiring hospitalisation such as pneumonia leading to acute respiratory failure, secondary bacterial respiratory infections, and death.
The standard of care is symptomatic treatment for cold/fever in uncomplicated flu for otherwise healthy patients, but added anti-retroviral medication in more seriously ill patients.
Study drug MHAA4549A is an antibody which attacks specific parts of the influenza virus. It is being developed for the treatment of hospitalised patients with severe influenza.The purpose of this study is to assess the safety, efficacy, and pharmacokinetics (how the drug moves in the body) of MHAA4549A compared with placebo in otherwise healthy patients with acute uncomplicated seasonal influenza A infection.
MHAA4549A has been shown to be safe and well tolerated in three completed
clinical studies, which altogether enrolled 136 healthy volunteers. In addition, an
ongoing global Phase 2b Study in 24 countries is currently enrolling hospitalised patients with severe influenza infection and has shown no clinically significant drug-related safety signals.Following screening, eligible patients will be randomised in a 1:1:1 ratio into three treatment groups: a single IV dose of 3600 mg MHAA4549A, a single IV dose of 8400 mg MHAA4549A, or a single IV dose of placebo. Study drug will be administered within 72 hours of onset of influenza-like illness and all patients will be followed for a minimum of 100 days from randomisation. There will be on site visits on Days 3, 5, and 7 and telephone visits on Days 2, 14, 30, and 100.
Study procedures will include blood, urine and PK sampling, vital signs and ECG.
Approximately 141 patients (47 per treatment arm) will be enrolled worldwide. The study is sponsored by Genentech, Inc.REC name
London - City & East Research Ethics Committee
REC reference
16/LO/1181
Date of REC Opinion
23 Aug 2016
REC opinion
Further Information Favourable Opinion