A Study of Acute Myocardial Infarction Using FDY-5301

NCT03470441 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: FDY-5301-201-US
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 23

Brief Summary

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.

Conditions

Acute Myocardial Infarction; STEMI

Outcome Measures

Primary Outcomes (4)

• Arrhythmias of Interest, 48 Hours (Overall)

  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)

  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)

  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)

  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 Outcomes (15)

• Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)

  72 hours post-treatment

• Infarct Size Relative to Ventricular Volume, 3 Months (Overall)

  3 months post-treatment

• Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)

  72 hours post-treatment

• Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)

  3 months post-treatment

• Left Ventricular End Systolic Volume Index, 72 Hours (Overall)

  72 hours post-treatment

Study Arms (4)

FDY-5301 Low Dose

EXPERIMENTAL

Anticipated n=20

Drug: FDY-5301

FDY-5301 Intermediate Dose

EXPERIMENTAL

Anticipated n=20

Drug: FDY-5301

FDY-5301 High Dose

EXPERIMENTAL

Anticipated n=20

Drug: FDY-5301

Placebo

PLACEBO COMPARATOR

Anticipated n=20

Other: Placebo

Interventions

FDY-5301 DRUG

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.

FDY-5301 High Dose; FDY-5301 Intermediate Dose; FDY-5301 Low Dose

Placebo OTHER

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.

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old male subjects
• to 80 year old female subjects who are not of child-bearing potential.
• 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)

You may not qualify if:

• Previous myocardial infarction
• Left bundle branch block (LBBB)
• Previous coronary artery bypass graft surgery (CABG)
• Major hemodynamic instability or uncontrolled ventricular arrhythmias
• Known contraindication to CMR
• Patients with known thyroid disease
• Subjects with past or current renal impairment requiring dialysis
• Pregnant or females of child bearing potential
• Body weight \> 120 kg or Body Mass Index (BMI) \> 35 kg/m2
• Use of investigational drugs or devices within 30 days prior to enrollment into the study.
• Life expectancy of less than 1 year due to non-cardiac pathology
• 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

Sponsors & Collaborators

• Faraday Pharmaceuticals, Inc.: lead

Study Sites (23)

Minneapolis Heart Institute

Minneapolis, Minnesota, 55047, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Budai Irgalmasrendi Kórház

Budapest, Hungary

Location

Magyar Honvédség Egészségügyi Központ

Budapest, Hungary

Location

Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika

Debrecen, Hungary

Location

Borsod-Abaúj-Zemplén Megyei Központi Kórház

Miskolc, Hungary

Location

Zala Megyei Szent Rafael Kórház

Zalaegerszeg, Hungary

Location

Samodzielny Publiczny Szpital Kliniczny Nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. Prof. Leszka Kieca., III Oddz. Kardiologii

Katowice, Silesian Voivodeship, Poland

Location

Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej

Grodzisk Mazowiecki, Poland

Location

Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej

Krakow, Poland

Location

Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Lodz, Poland

Location

Miedziowe Centrum Zdrowia

Lubin, Poland

Location

Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Poland

Location

KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny

Wroclaw, Poland

Location

Royal Devon and Exeter Hospital Cardiology Department

Exeter, Devon, United Kingdom

Location

Wythenshawe Hospital

Manchester, Greater Manchester, United Kingdom

Location

Glenfield Hospital

Leicester, Leicestershire, United Kingdom

Location

University of Oxford

Oxford, Oxfordshire, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Location

New Cross Hospital

Wolverhampton, West Midlands, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

Related Publications (1)

• Adlam D, Zarebinski M, Uren NG, Ptaszynski P, Oldroyd KG, Munir S, Zaman A, Contractor H, Kiss RG, Edes I, Szachniewicz J, Nagy GG, Garcia MJ, Tomcsanyi J, Irving J, Sharp ASP, Musialek P, Lupkovics G, Shirodaria C, Selvanayagam JB, Quinn P, Ng L, Roth M, Insko MA, Haber B, Hill S, Siegel L, Tulloch S, Channon KM. A Randomized, double-blind, dose ranging clinical trial of intravenous FDY-5301 in acute STEMI patients undergoing primary PCI. Int J Cardiol. 2022 Jan 15;347:1-7. doi: 10.1016/j.ijcard.2021.11.016. Epub 2021 Nov 12.

  PMID: 34774885 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Faraday Pharmaceuticals, Inc

info@faradaypharma.com

206-492-5310

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects who fulfill all study eligibility criteria will be randomized to receive one of the 4 treatments.

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 20, 2018
• Study Start: October 27, 2017
• Primary Completion: July 14, 2018
• Study Completion: January 3, 2019
• Last Updated: January 16, 2026
• Results First Posted: December 14, 2021

Record last verified: 2021-11

Locations

US (2); GB (9); PL (7); HU (5)