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A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers

Myocardial Infarction Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Phase 1 Study of the Safety and Tolerability of the Intravenous Administration of Thymosin Beta 4 and Its Pharmacokinetics After Single and Multiple Doses in Healthy Volunteers

Clinical Trial Summary

The purpose of this study is to determine whether the intravenous administration of single- and multiple-ascending doses of Thymosin Beta 4 is safe and tolerable in healthy volunteers.

Clinical Trial Description

The cardio-protective effect of Tβ4 treatment was shown in a permanently ligated mouse model.The authors demonstrated that systemic Tβ4 treatment (intraperitoneal, intracardiac, or i.p. plus intracardiac) every third day enhanced early myocyte survival and significantly improved cardiac function. Several weeks after the heart attack, it was evident that mice treated with Tβ4 had less muscle damage and stronger hearts compared with mice treated with placebo. Specifically, Tβ4 treatment significantly improved fractional shortening by about 60% and ejection fraction by about 100% and myocardial salvage by about 53% when compared with controls. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00743769
Study type Interventional
Source RegeneRx Biopharmaceuticals, Inc.
Contact
Status Withdrawn
Phase Phase 1
Start date April 2008
Completion date January 1, 2017
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