A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction

• Status: Withdrawn
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the safety and tolerability of two active doses of RGN-352 (thymosin beta 4, Tβ4, Injectable Solution) in patients with acute myocardial infarction receiving percutaneous coronary intervention angioplasty with or without stent placement. Approximately 75 subjects will be randomized to receive one of two RGN-352 doses of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3 consecutive days and weekly for 4 more weeks.

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

Details

• Lead Sponsor: RegeneRx Biopharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Male and female subjects

2. Negative urine pregnancy test at Screening

3. An electrocardiogram

4. First acute anterior MI

5. Baseline angiography

6. Onset of chest pain symptoms to initial PCI angioplasty time is 2 to 6 hours

7. Written informed consent reviewed and signed by the subject or legally authorized representatives

Exclusion Criteria:

1. Intention to treat subject with thrombolytic therapy following assertion of Thrombolysis In Myocardial Infarction(TIMI) flow 0 or 1 during qualifying angiogram

2. History of Myocardial infarctionI or congestive heart failure

3. Non-atherosclerotic etiology of acute myocardial infarction

4. Cardiogenic shock (systolic blood pressure <90 despite adequate left ventricle filling pressure or requiring catecholamines) or other hemodynamic instability at baseline

5. Further transcatheter or surgical revascularization, e.g., coronary artery bypass graft planned per baseline angiogram

6. Lactating women

7. Past or present evidence of malignancy

8. Women who have had menarche but have not completed menopause, have not been surgically sterilized (bilateral tubal ligation or hysterectomy), do not have a partner with documented sterility (including vasectomy), or are not using adequate contraception (combined hormonal or double-barrier method of contraception, or sexual abstinence are the only methods of contraception acceptable for this study)

9. Ongoing infectious disease including human immunodeficiency virus (HIV) and hepatitis

10. Clinically significant respiratory, renal, metabolic, liver, central nervous system or other comorbid disease, except current cardiovascular disease