A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers
NCT00743769 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2017-04-17
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.
Conditions
- Myocardial Infarction
- Myocardial Ischemia
Interventions
- 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
- OTHER
-
Placebo
Single bolus injections of ascending doses of 0.00 mg QD of thymosin beta 4
Sponsors & Collaborators
-
RegeneRx Biopharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Dennis Ruff, MD · Healthcare Discoveries LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2017-01-01
- Completion
- 2017-01-01
Countries
- United States
Study Locations
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