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

This study has been completed.
Sponsor:
Information provided by:
RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00743769
First received: August 27, 2008
Last updated: December 16, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Myocardial Ischemia
Drug: thymosin beta 4
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by RegeneRx Biopharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2

Thymosin Beta 4

A single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD

Drug: thymosin beta 4
Single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 of thymosin beta 4
Placebo Comparator: 1
Placebo A single bolus injection of 0.0 mg of thymosin beta 4 QD
Other: Placebo
Single bolus injections of ascending doses of 0 mg of thymosin beta 4

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743769

Locations
United States, Texas
Healthcare Discoveries LLC
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
RegeneRx Biopharmaceuticals, Inc.
Investigators
Principal Investigator: Dennis Ruff, MD HCD
  More Information

No publications provided

Responsible Party: David Crockford, VP, Clinical and Regulatory Affairs, RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00743769     History of Changes
Other Study ID Numbers: RGN-MI-101
Study First Received: August 27, 2008
Last Updated: December 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by RegeneRx Biopharmaceuticals, Inc.:
Myocardial Infarction
Myocardial Ischemia
Myocardial Diseases
Infarction

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Infarction
Ischemia
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on April 16, 2014