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

RegeneRx Biopharmaceuticals, Inc.

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Myocardial Infarction Myocardial Ischemia

Interventions

thymosin beta 4DRUG

Single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD of thymosin beta 4

PlaceboOTHER

Single bolus injections of ascending doses of 0.00 mg QD of thymosin beta 4

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * In good health with no underlying medical condition that, according to the Investigator, would place a subject at risk * Having given written informed consent Exclusion Criteria: * Evidence of any malignancy * Use of any tobacco product within 7 years of study entry * Pregnant or lactating women * History of drug abuse * Clinically significant abnormal screening ECG * Abnormal vital signs * Use of systemic steroidal therapy), immunotherapy, cytotoxic, chemotherapy or any investigational drug or device within 30 days of study entry. Topical steroids are allowed * Women, 40 years of age and above, who have not had a mammography within one year of study entry * Men and women, 50 years of age and above, who have not had a sigmoidoscopy within 5 years and colonoscopy within 10 years of study entry

Locations (1)

Healthcare Discoveries LLC

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Evaluate safety parameters in single-ascending doses of Tβ4(42 mg, 140 mg, 420 mg or 1,260 mg per dose) administered intravenously to healthy volunteers, such as ECG, vital signs,lab tests, etc.

Time frame: one day

Secondary Outcomes

Evaluate pharmacokinetic parameters in single-ascending doses of Tβ4(42 mg, 140 mg, 420 mg or 1,260 mg per dose) administered intravenously to healthy volunteers

Time frame: one day

Data from ClinicalTrials.gov

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