A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers
Brief 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.
Detailed 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.
Interventions
Primary Outcomes
Trial Information
NCT00743769
Withdrawn
INTERVENTIONAL
PHASE1
RegeneRx Biopharmaceuticals, Inc.
December 15, 2025