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

Phase 1

Withdrawn

• Conditions: Myocardial Ischemia; Myocardial Infarction
• Interventions: Other: Placebo; Drug: thymosin beta 4

• Registration Number: NCT00743769
• Lead Sponsor: RegeneRx Biopharmaceuticals, Inc.

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo A single bolus injection of 0.0 mg QD of thymosin beta 4
2	thymosin beta 4	Thymosin Beta 4 A single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD (once a day)

Primary Outcome Measures

Name	Time	Method
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.	one day

Secondary Outcome Measures

Name	Time	Method
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	one day

Trial Locations

Locations (1)

Healthcare Discoveries LLC; 🇺🇸 San Antonio, Texas, United States