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

NCT ID: NCT00743769

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2017-01-01

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.

Conditions

Myocardial Infarction; Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

2

Thymosin Beta 4

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

Group Type: ACTIVE_COMPARATOR

thymosin beta 4

Intervention Type: DRUG

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

1

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

thymosin beta 4

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RegeneRx Biopharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Ruff, MD

Role: PRINCIPAL_INVESTIGATOR

Healthcare Discoveries LLC

Locations

Healthcare Discoveries LLC

San Antonio, Texas, United States

Countries

United States

Other Identifiers

RGN-MI-101

Identifier Type: -

Identifier Source: org_study_id