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

RegeneRx Biopharmaceuticals

Status and phase: Withdrawn; Phase 1

Conditions: Myocardial Ischemia; Myocardial Infarction

Treatments: Drug: thymosin beta 4; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00743769

RGN-MI-101

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

2

Active Comparator group

Description:

Thymosin Beta 4 A single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD (once a day)

Treatment:

Drug: thymosin beta 4

1

Placebo Comparator group

Description:

Placebo A single bolus injection of 0.0 mg QD of thymosin beta 4

Treatment:

Other: Placebo