Status:
WITHDRAWN
A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers
Lead Sponsor:
RegeneRx Biopharmaceuticals, Inc.
Conditions:
Myocardial Infarction
Myocardial Ischemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
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 intracard...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00743769
Start Date
April 1 2008
End Date
January 1 2017
Last Update
April 17 2017
Active Locations (1)
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1
Healthcare Discoveries LLC
San Antonio, Texas, United States, 78209