A Study of Acute Myocardial Infarction Using FDY-5301

December 26, 2025 updated by: Faraday Pharmaceuticals, Inc.

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called FDY-5301 as a possible treatment to reduce the size of the injury to the heart caused by the heart attack. An experimental drug is one that is being tested and is not approved by the United States Food and Drug Administration (FDA).

A heart attack occurs when a heart (coronary) artery supplying blood to the heart muscle becomes blocked and the heart muscle is injured. You will be having a cardiac catheterization procedure to clear the blockage in your coronary artery that caused your heart attack. This procedure works well but may not completely prevent some injury to the heart muscle which occurs when the blood supply is initially restored to the heart. This is known as "reperfusion injury".

FDY-5301 is a single intravenous injection. About 80 subjects are expected to participate in this study at about 20 research sites in the United States and Europe. Each subject's participation is expected to last about 6 months after receiving the study drug.

Subjects who meet all inclusion criteria will be randomly assigned to one of 4 study groups. Three groups will receive FDY-5301 (low, intermediate, or high dose) and 1 group will receive a placebo.The study drug (FDY-5301 or placebo) will be given through a vein (intravenously) during the catheterization procedure. This is a double-blind study so neither the patient nor study personnel will know whether the dose is active drug or placebo until the end of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
        • Magyar Honvedseg Egeszsegugyi Kozpont
      • Budapest, Hungary
        • Budai Irgalmasrendi Kórház
      • Debrecen, Hungary
        • Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika
      • Miskolc, Hungary
        • Borsod-Abaúj-Zemplén Megyei Központi Kórház
      • Zalaegerszeg, Hungary
        • Zala Megyei Szent Rafael Kórház
  • Poland
      • Grodzisk Mazowiecki, Poland
        • Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
      • Krakow, Poland
        • Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
      • Lodz, Poland
        • Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
      • Lubin, Poland
        • Miedziowe Centrum Zdrowia
      • Warsaw, Poland
        • Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie
      • Wroclaw, Poland
        • KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland
        • Samodzielny Publiczny Szpital Kliniczny Nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. Prof. Leszka Kieca., III Oddz. Kardiologii
  • United Kingdom
      • Dundee, United Kingdom
        • Ninewells Hospital and Medical School
      • Edinburgh, United Kingdom
        • Royal Infirmary of Edinburgh
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital
    • Devon
      • Exeter, Devon, United Kingdom
        • Royal Devon and Exeter Hospital Cardiology Department
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom
        • Wythenshawe Hospital
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom
        • Glenfield Hospital
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom
        • University of Oxford
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom
        • Freeman Hospital
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom
        • New Cross Hospital
  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55047
        • Minneapolis Heart Institute
    • New York
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18-80 year old male subjects
  2. 18 to 80 year old female subjects who are not of child-bearing potential.
  3. Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG criteria (ST-elevation at the J-point in two contiguous leads with the cut-off points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads), within 12 hours of symptom onset.

Written informed consent prior to study participation (either by the subject or a legally authorized representative of the subject)

Exclusion Criteria:

  1. Previous myocardial infarction
  2. Left bundle branch block (LBBB)
  3. Previous coronary artery bypass graft surgery (CABG)
  4. Major hemodynamic instability or uncontrolled ventricular arrhythmias
  5. Known contraindication to CMR
  6. Patients with known thyroid disease
  7. Subjects with past or current renal impairment requiring dialysis
  8. Pregnant or females of child bearing potential
  9. Body weight > 120 kg or Body Mass Index (BMI) > 35 kg/m2
  10. Use of investigational drugs or devices within 30 days prior to enrollment into the study.
  11. Life expectancy of less than 1 year due to non-cardiac pathology
  12. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FDY-5301 Low Dose
Anticipated n=20
Drug: FDY-5301
FDY-5301 will be administered once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
Experimental: FDY-5301 Intermediate Dose
Anticipated n=20
Drug: FDY-5301
FDY-5301 will be administered once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
Experimental: FDY-5301 High Dose
Anticipated n=20
Drug: FDY-5301
FDY-5301 will be administered once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
Placebo Comparator: Placebo
Anticipated n=20
Other: Placebo
Placebo will be administered intravenously by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Arrhythmias of Interest, 48 Hours (Overall)
Time Frame: First 48 hours post-treatment
Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
First 48 hours post-treatment
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
Time Frame: 48 hours post-treatment
Incidence rate of clinically relevant arrhythmias during the first 48 hours post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
48 hours post-treatment
Arrhythmias of Interest, 14 Days (Overall)
Time Frame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
Time Frame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Incidence rate of clinically relevant arrhythmias 48 hours to 14 days post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
Time Frame: 72 hours post-treatment
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Overall)
Time Frame: 3 months post-treatment
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
3 months post-treatment
Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)
Time Frame: 72 hours post-treatment
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment)
72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
Time Frame: 3 months post-treatment
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
3 months post-treatment
Left Ventricular End Systolic Volume Index, 72 Hours (Overall)
Time Frame: 72 hours post-treatment
Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
72 hours post-treatment
Left Ventricular End Systolic Volume Index, 3 Months (Overall)
Time Frame: 3 months post-treatment
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
3 months post-treatment
Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)
Time Frame: 72 hours post-treatment
Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment
72 hours post-treatment
Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
Time Frame: 3 months post-treatment
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
3 months post-treatment
Left Ventricular Ejection Fraction, 72 Hours (Overall)
Time Frame: 72 hours post-treatment
Left ventricular ejection fraction at 72 hours post-treatment
72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Overall)
Time Frame: 3 months post-treatment
Left Ventricular Ejection Fraction at 3 Months (Overall)
3 months post-treatment
Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
Time Frame: 72 hours post-treatment
Left ventricular ejection fraction at 72 hours post-treatment
72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
Time Frame: 3 months post-treatment
Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)
3 months post-treatment
Serum Troponin Concentrations, 48 Hours (Overall)
Time Frame: 48 hours post-treatment
Area under the curve of serum troponins measured over 48 hours post-treatment
48 hours post-treatment
Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
Time Frame: 48 hours post-treatment
Area under the curve of serum troponins measured over 48 hours post-treatment
48 hours post-treatment
ST-segment Resolution
Time Frame: 4 hours post-dose
Proportion of patients with ST-segment resolution at 4 hours post-dose
4 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Faraday Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shannon Wilson, Faraday Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FDY-5301-201-US

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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