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

This study has been withdrawn prior to enrollment.
(Study never initiated due to contract manufacturing issues)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743769
First Posted: August 29, 2008
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
RegeneRx Biopharmaceuticals, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

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 ]

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 ]

Enrollment: 0
Study Start Date: April 2008
Study Completion Date: January 1, 2017
Primary Completion Date: January 1, 2017 (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 (once a day)

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
Placebo Comparator: 1
Placebo A single bolus injection of 0.0 mg QD of thymosin beta 4
Other: Placebo
Single bolus injections of ascending doses of 0.00 mg QD 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Healthcare Discoveries LLC
  More Information

Responsible Party: RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00743769     History of Changes
Other Study ID Numbers: RGN-MI-101
First Submitted: August 27, 2008
First Posted: August 29, 2008
Last Update Posted: April 17, 2017
Last Verified: April 2017

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

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