NCT00743769

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: RegeneRx Biopharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myocardial Infarction
• Myocardial Ischemia

Interventions

Type	Name	Description
DRUG	thymosin beta 4	Single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD of thymosin beta 4
OTHER	Placebo	Single bolus injections of ascending doses of 0.00 mg QD of thymosin beta 4

Timeline

• Start date: 2008-04-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2008-08-29
• Last updated: 2017-04-17

Locations

1 site across 1 country: United States