Phase 2 Study of FDY-5301 for the Prevention and Treatment of ICUAW
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Intravenous FDY-5301 for the Prevention and Treatment of ICU Acquired Weakness in Major Trauma Patients
IRAS ID
276488
Contact name
Zudin Puthucheary
Contact email
Sponsor organisation
Faraday Pharmaceuticals, Inc.
Eudract number
2019-003429-66
Duration of Study in the UK
0 years, 18 months, 0 days
Research summary
Intensive care unit acquired weakness (ICUAW) is characterised by muscle weakness and wasting for which no cause can be identified besides the acute illness or its treatment. It has been observed to last from a few weeks to years.
ICUAW may be a major part of long-term, post-intensive care syndrome (PICS) which are health problems that can remain after patients are discharged from the ICU and includes physical, mental and cognitive dysfunction which can have a major impact on the quality of life of the growing population of ICU survivors. ICUAW has also been associated with reduced life expectancy 12 months after hospital discharge.
FDY-5301 is being developed by Faraday Pharmaceuticals Inc. to improve the inflammatory response and consequent tissue damage and immune dysfunction for the treatment of critical care diseases, such as ICUAW.
This is a Phase II randomised, double-blind and parallel-group comparison study where participants will either receive the study medication FDY-5301 (dose of 1 or 2mg/kg) or placebo (volume matched normal saline solution) administered by IV bolus injection once daily for up to 7 days.
Approximately 252 participants between 18 and 75 years old are expected to be enrolled across 12 research sites globally, with an overall patient participation of approximately 6 months.
The study will consist of 3 phases; The screening period, The in-hospital stay and the follow-up visits.
The purpose of this study is to see if FDY-5301 can help prevent muscle weakness and to help patients recover better by protecting their bodies from further tissue damage and organ failure after major trauma, as well as to see if FDY-5301 is safe for ICU major trauma patients.
The study will also determine if FDY-5301 affects things like overall functioning, survival and quality of life after discharge
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0177
Date of REC Opinion
17 Sep 2021
REC opinion
Further Information Unfavourable Opinion