A Study of Acute Myocardial Infarction Using FDY-5301

• Status: Completed
• Trial end date: 2019-01-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faraday Pharmaceuticals, Inc.

Criteria

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