A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers
Primary Purpose
Myocardial Infarction, Myocardial Ischemia
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
thymosin beta 4
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Myocardial Ischemia, Myocardial Diseases, Infarction
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
Sites / Locations
- Healthcare Discoveries LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
2
1
Arm Description
Thymosin Beta 4 A single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD (once a day)
Placebo A single bolus injection of 0.0 mg QD of thymosin beta 4
Outcomes
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.
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
Full Information
NCT ID
NCT00743769
First Posted
August 27, 2008
Last Updated
April 13, 2017
Sponsor
RegeneRx Biopharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00743769
Brief Title
A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study never initiated due to contract manufacturing issues
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RegeneRx Biopharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Myocardial Ischemia
Keywords
Myocardial Infarction, Myocardial Ischemia, Myocardial Diseases, Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
Thymosin Beta 4
A single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD (once a day)
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo A single bolus injection of 0.0 mg QD of thymosin beta 4
Intervention Type
Drug
Intervention Name(s)
thymosin beta 4
Intervention Description
Single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD of thymosin beta 4
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Single bolus injections of ascending doses of 0.00 mg QD of thymosin beta 4
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Ruff, MD
Organizational Affiliation
Healthcare Discoveries LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthcare Discoveries LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers
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