Phase 2A Study of IV FDY-5301 in Acute Myocardial Infarction
Research type
Research Study
Full title
A Phase 2A, Randomized, Double-Blind, Placebo- Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction
IRAS ID
222650
Contact name
Keith Channon
Contact email
Sponsor organisation
Faraday Pharmaceuticals, Inc.
Eudract number
2017-000047-41
Duration of Study in the UK
1 years, 4 months, 27 days
Research summary
ST Segment Elevation Myocardial Infarction (STEMI) is the name cardiologists currently use to describe a classic heart attack. The first line of therapy for STEMI includes the restoring of the blood flow to the coronary artery using mechanical methods (such as angioplasty, the widening of the vessels using a balloon catheter). However, this does not take into account the damage to the tissue, caused by the absence of oxygen, when restoring the myocardial tissue. \n\nThe aim of developing FDY-5301 in acute myocardial infarction (AMI) is to reduce size of the tissue damage, and consequently improve short and longer-term outcomes after AMI/reperfusion. Preclinical data to date shows that when administering FDY-5301 in conjunction with surgery results in reduction of injury size.\n \nAt least 80 evaluable subjects will be enrolled and randomized to receive either FDY-5301 at doses of 0.5 mg/kg, 1.0mg/kg, 2.0mg/kg or placebo. STEMI diagnosis will be made based on clinical and ECG findings. Study drug administration will occur by bolus injection at any time between an hour and 5 minutes prior to coronary reperfusion. Subjects are expected to remain involved in the Study for up to 6 months.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0242
Date of REC Opinion
6 Jul 2017
REC opinion
Favourable Opinion