A Phase 2 interventional study of FDY-5301 and Placebo in Acute Myocardial Infarction and STEMI, sponsored by Faraday Pharmaceuticals, Inc.. Completed at 23 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Faraday Pharmaceuticals, Inc. · Phase 2, Interventional, and Other
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.
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.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's enrollment of 120 is below the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Faraday Pharmaceuticals, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Written prior to study participation (either by the subject or a legally authorized representative of the subject)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anticipated n=20
Drug: FDY-5301
Anticipated n=20
Drug: FDY-5301
Anticipated n=20
Drug: FDY-5301
Anticipated n=20
Other: Placebo
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 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
Arrhythmias of Interest, 48 Hours (Overall)
Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
Time frame: 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
Time frame: 48 hours post-treatment
Arrhythmias of Interest, 14 Days (Overall)
Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
Time frame: 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
Time frame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
Time frame: 72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Overall)
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Time frame: 3 months post-treatment
Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment)
Time frame: 72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Time frame: 3 months post-treatment
Left Ventricular End Systolic Volume Index, 72 Hours (Overall)
Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
Time frame: 72 hours post-treatment
Left Ventricular End Systolic Volume Index, 3 Months (Overall)
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Time frame: 3 months post-treatment
Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)
Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment
Time frame: 72 hours post-treatment
Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Time frame: 3 months post-treatment
Left Ventricular Ejection Fraction, 72 Hours (Overall)
Left ventricular ejection fraction at 72 hours post-treatment
Time frame: 72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Overall)
Left Ventricular Ejection Fraction at 3 Months (Overall)
Time frame: 3 months post-treatment
Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
Left ventricular ejection fraction at 72 hours post-treatment
Time frame: 72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)
Time frame: 3 months post-treatment
Serum Troponin Concentrations, 48 Hours (Overall)
Area under the curve of serum troponins measured over 48 hours post-treatment
Time frame: 48 hours post-treatment
Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
Area under the curve of serum troponins measured over 48 hours post-treatment
Time frame: 48 hours post-treatment
ST-segment Resolution
Proportion of patients with ST-segment resolution at 4 hours post-dose
Time frame: 4 hours post-dose
The first participant enrolled on October 27, 2017 in study centers in Poland, Hungary, UK, and the United States.
| Milestone | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Started | 29 | 31 | 31 | 29 |
| Completed | 28 | 26 | 29 | 25 |
| Not completed | 1 | 5 | 2 | 4 |
| Withdrew: Death | 0 | 1 | 1 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 4 | 1 | 3 |
Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
| participants | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Ventricular Fibrillation | 0 | 0 | 0 | 0 |
| Sustained Ventricular Tachycardia | 0 | 0 | 0 | 0 |
| Non-Sustained Ventricular Tachycardia | 1 | 1 | 7 | 2 |
| High-Degree AV Block | 0 | 0 | 2 | 0 |
| Atrial Fibrillation | 0 | 2 | 1 | 1 |
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
| Percentage | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Ventricular Fibrillation | 0 | 0 | 0 | 0 |
| Sustained Ventricular Tachycardia | 0 | 0 | 0 | 0 |
| Non-Sustained Ventricular Tachycardia | .0766 | .0797 | .548 | .168 |
| High-Degree AV Block | 0 | 0 | .157 | 0 |
| Atrial Fibrillation | 0 | .159 | .0783 | .0838 |
Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
| participants | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Ventricular Fibrillation | 0 | 0 | 0 | 0 |
| Sustained Ventricular Tachycardia | 0 | 0 | 0 | 0 |
| Non-Sustained Ventricular Tachycardia | 0 | 1 | 0 | 0 |
| High-Degree AV Block | 0 | 0 | 2 | 0 |
| Atrial Fibrillation | 3 | 2 | 2 | 1 |
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
| Percentage | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Ventricular Fibrillation | 0 | 0 | 0 | 0 |
| Sustained Ventricular Tachycardia | 0 | 0 | 0 | 0 |
| Non-Sustained Ventricular Tachycardia | 0 | 0.0147 | 0 | 0 |
| High-Degree AV Block | 0 | 0 | 0.0295 | 0 |
| Atrial Fibrillation | 0.0475 | 0.0293 | 0.0295 | 0.0166 |
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
| INF/VV (%) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) | 19.1 (0 to 50.2) | 16.9 (0 to 51.3) | 19.6 (5.2 to 51.4) | 20.4 (0 to 60.3) |
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
| INF/VV (%) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Infarct Size Relative to Ventricular Volume, 3 Months (Overall) | 11.7 (0 to 52) | 11.4 (0 to 50.7) | 8.5 (0 to 49.5) | 14.9 (0 to 48.4) |
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment)
| INF/VV (%) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) | 33 (0 to 39.9) | 15.8 (0 to 51.3) | 12.1 (9.8 to 45.8) | 26.7 (0 to 60.3) |
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
| INF/VV (%) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) | 19.7 (0 to 52) | 10.4 (0 to 50.7) | 9.3 (0 to 34.4) | 22.8 (1.4 to 48.4) |
Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
| mL/kg/M2 | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Left Ventricular End Systolic Volume Index, 72 Hours (Overall) | 40 (20 to 65.2) | 32 (15 to 72) | 32 (12 to 68) | 38 (18 to 53) |
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
| mL/kg/M2 | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Left Ventricular End Systolic Volume Index, 3 Months (Overall) | 29 (15 to 78) | 25.5 (7 to 100) | 27 (10 to 73) | 36 (14 to 67) |
Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment
| mL/kg/M2 | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts) | 45.5 (21 to 65.2) | 32 (15 to 48) | 31 (13.1 to 41) | 42 (18 to 53) |
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
| mL/kg/M2 | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts) | 37 (16 to 68) | 28 (7 to 43) | 23.5 (14 to 40) | 36 (19 to 67) |
Left ventricular ejection fraction at 72 hours post-treatment
| Percentage | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Left Ventricular Ejection Fraction, 72 Hours (Overall) | 51.4 (31.2 to 69.5) | 51.7 (33.8 to 78.6) | 54.5 (35.9 to 75.1) | 48.7 (35.2 to 73.5) |
Left Ventricular Ejection Fraction at 3 Months (Overall)
| Percentage | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Left Ventricular Ejection Fraction, 3 Months (Overall) | 59.5 (29 to 72.4) | 58.9 (25 to 87.5) | 63.2 (36.8 to 72.1) | 53.9 (39.1 to 76.9) |
Left ventricular ejection fraction at 72 hours post-treatment
| Percentage | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts) | 48 (34.4 to 69.5) | 51.7 (33.8 to 78.6) | 57.3 (35.9 to 75.1) | 43.2 (35.2 to 73.5) |
Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)
| Percentage | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts) | 55.7 (34.9 to 72.4) | 57.2 (45.2 to 87.5) | 67.6 (48 to 72.1) | 50.4 (41.2 to 76.9) |
Area under the curve of serum troponins measured over 48 hours post-treatment
| AUC4-48 µg/L | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Serum Troponin Concentrations, 48 Hours (Overall) | 90.5 (-19.3 to 383) | 98.1 (0.0274 to 538) | 108 (32.8 to 591) | 112 (4.5 to 752) |
Area under the curve of serum troponins measured over 48 hours post-treatment
| AUC4-48 µg/L | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Serum Troponin Concentrations, 48 Hours (Anterior Infarcts) | 123 (-19.3 to 3361) | 55 (0.0274 to 538) | 111 (32.8 to 591) | 83.8 (42.5 to 752) |
Proportion of patients with ST-segment resolution at 4 hours post-dose
| percentage | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| ST-segment Resolution | 48.0 | 68.0 | 52.4 | 47.4 |
Collected over Day 1 to 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental FDY-5301 Low Dose | 0/29 (0%) | 7/29 (24.1%) | 9/29 (31%) |
| Experimental FDY-5301 Intermediate Dose | 1/31 (3.2%) | 7/31 (22.6%) | 4/31 (12.9%) |
| Experimental FDY-5301 High Dose | 1/31 (3.2%) | 4/31 (12.9%) | 9/31 (29%) |
| Placebo | 1/29 (3.4%) | 8/29 (27.6%) | 18/29 (62.1%) |
| Event | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 2/29 | 0/31 | 0/31 | 0/29 |
| Angina pectorisCardiac disorders | 0/29 | 1/31 | 2/31 | 0/29 |
| Ventricular fibrillationCardiac disorders | 0/29 | 2/31 | 0/31 | 1/29 |
| Chest painGeneral disorders | 0/29 | 2/31 | 0/31 | 0/29 |
| Cardiogenic shockCardiac disorders | 0/29 | 1/31 | 1/31 | 1/29 |
| Coronary artery diseaseCardiac disorders | 1/29 | 1/31 | 0/31 | 0/29 |
| Acute myocardial infarctionCardiac disorders | 1/29 | 0/31 | 0/31 | 0/29 |
| Cardiac failureCardiac disorders | 0/29 | 0/31 | 0/31 | 1/29 |
| Cardiac ventricular thrombosisCardiac disorders | 1/29 | 0/31 | 0/31 | 0/29 |
| Coronary artery dissectionCardiac disorders | 1/29 | 0/31 | 0/31 | 0/29 |
| Event | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo |
|---|---|---|---|---|
| Chest painGeneral disorders | 1/29 | 0/31 | 4/31 | 1/29 |
| DiarrhoeaGastrointestinal disorders | 1/29 | 0/31 | 0/31 | 3/29 |
| HeadacheNervous system disorders | 0/29 | 0/31 | 0/31 | 3/29 |
| Ventricular tachycardiaCardiac disorders | 0/29 | 2/31 | 3/31 | 1/29 |
| Cardiac failureCardiac disorders | 2/29 | 0/31 | 1/31 | 0/29 |
| ConstipationGastrointestinal disorders | 2/29 | 0/31 | 0/31 | 0/29 |
| DizzinessNervous system disorders | 1/29 | 0/31 | 0/31 | 2/29 |
| HaematomaVascular disorders | 2/29 | 0/31 | 0/31 | 0/29 |
| Peripheral coldnessVascular disorders | 0/29 | 0/31 | 0/31 | 2/29 |
| Viral upper respiratory tract infectionInfections and infestations | 0/29 | 0/31 | 0/31 | 2/29 |
| Age, Categorical(Participants) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 22 | 17 | 18 | 71 |
| >=65 years | 15 | 9 | 14 | 11 | 49 |
| Sex: Female, Male(Participants) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo | Total |
|---|---|---|---|---|---|
| Female | 5 | 11 | 11 | 10 | 37 |
| Male | 24 | 20 | 20 | 19 | 83 |
| Ethnicity (NIH/OMB)(Participants) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 | 1 | 3 |
| Not Hispanic or Latino | 29 | 30 | 30 | 28 | 117 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 1 |
| Asian | 0 | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 0 | 1 |
| White | 29 | 27 | 30 | 27 | 113 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 | 1 | 3 |
| Region of Enrollment(participants) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo | Total |
|---|---|---|---|---|---|
| Hungary | 7 | 8 | 9 | 6 | 30 |
| United States | 0 | 2 | 1 | 3 | 6 |
| Poland | 7 | 5 | 6 | 2 | 20 |
| United Kingdom | 15 | 16 | 15 | 18 | 64 |
| BMI(kg/m2) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 27.1 ± 4.17 | 28 ± 4.29 | 28.1 ± 4.88 | 28.5 ± 4.43 | 27.9 ± 4.43 |
| Height(cm) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 173 ± 7.8 | 171 ± 8.2 | 170 ± 10.7 | 170 ± 8.3 | 171 ± 8.8 |
| Weight(kg) | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 81.62 ± 14.703 | 81.76 ± 13.453 | 81.52 ± 15.749 | 82.23 ± 15.162 | 81.78 ± 14.601 |
PDFs hosted by the registry, ClinicalTrials.gov.
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ST Elevation Myocardial Infarction →
Faraday Pharmaceuticals, Inc.