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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00743769
• Other study ID #: RGN-MI-101
• Status: Withdrawn
• Phase: Phase 1
• First received: August 27, 2008
• Last updated: April 13, 2017
• Start date: April 2008
• Est. completion date: January 1, 2017

Study information

• Verified date: April 2017
• Source: RegeneRx Biopharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Healthcare Discoveries LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
RegeneRx Biopharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate safety parameters in single-ascending doses of Tß4(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.		one day
Secondary	Evaluate pharmacokinetic parameters in single-ascending doses of Tß4(42 mg, 140 mg, 420 mg or 1,260 mg per dose) administered intravenously to healthy volunteers		one day