DRUG
Drug: Placebo
Injectable administration by slow intravenous bolus, 0.00% Thymosin Beta 4 daily for 3 days then weekly for 4 consecutive weeks
Status
Withdrawn
Phase
Phase 2
Enrollment
0
Locations
0
Results
Not posted
Publications
0
Study 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.
This is a double-blind, placebo controlled, parallel-group, dose finding study. Eligible subjects will be randomized to receive one of two doses of RGN-352 or matching placebo with an equal allocation ratio (i.e., 1:1:1). Approximately 75 subjects will be randomized to study treatment to achieve at least 60 evaluable subjects with 20 to 25 subjects per group. 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 consecutive weeks. Study subjects will undergo cardiac angiography to assess initial coronary artery patency and Thrombolysis In Myocardial Infarction flow grade both pre- and post-percutaneous coronary intervention (PCI) angioplasty. A total of 7 doses will be administrated over the treatment period. The first dose of either RGN-352 or placebo will be administered to randomized subjects following PCI angioplasty and specifically within 30 minutes after balloon deflation, with a further 2 doses. The remaining 4 doses will be given weekly for 4 consecutive weeks. Follow-up is on Months 2, 4, and 6.
Interventions
DRUG
Injectable administration by slow intravenous bolus, 0.00% Thymosin Beta 4 daily for 3 days then weekly for 4 consecutive weeks
DRUG
Injectable administration of Thymosin Beta 4 by intravenous bolus at 1200 mg, or 450 mg daily for 3 days then weekly for 4 consecutive weeks
Timeline
First posted
Mar 9, 2011
Study start
Jul 2019
Primary completion
Jul 2020
Study completion
Jul 2020
Results posted
Not reported
Registry updated
Sep 22, 2021
Outcomes
Total MRI infarct zone derived from cardiac MRI scan
Time frame · Day 28
MRI-derived myocardial salvage index, mass, Left Ventricle (LV) ejection fraction,systolic and end diastolic volumes
Time frame · Day 28
Eligibility
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
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Beijing Northland Biotech. Co., Ltd. · Acute Myocardial Infarction (AMI) · Acute Myocardial Infarction of Anterior Wall
Phase 2
Not yet recruiting
189
2026-05
Hudson Biotech · Atherosclerotic Cardiovascular Diseases · Endothelial Dysfunction
Phase 1 / Phase 2
Recruiting
80
2026-03
ReGenTree, LLC · Neurotrophic Keratopathy
Phase 3
Recruiting
70
2025-12
Beijing Northland Biotech. Co., Ltd. · Acute Myocardial Infarction
Phase 2
Completed
90
2024-06
Beijing Northland Biotech. Co., Ltd. · Acute Myocardial Infarction
Phase 2
Completed
62
2022-08
ReGenTree, LLC · Dry Eye Syndromes · Dry Eye
Phase 3
Completed
700
2022-05
ReGenTree, LLC · Dry Eye Syndrome
Phase 3
Completed
601
2022-01
Beijing Northland Biotech. Co., Ltd. · Healthy
Phase 1
Completed
54
2020-09
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.