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A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers
Plain-language guide to NCT00743769: phase 1 randomized trial of TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length). Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00743769
- Phase
- phase 1
- Status
- withdrawn
- Start
- 2008-04
- Completion (planned or actual)
- 2017-01-01
- Participants
- n/a (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Myocardial Infarction; Myocardial Ischemia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length).
It had two arms (groups): 2 (active comparator) and 1 (placebo comparator).
The registry classes the interventions as drug and other.
More on the Plan
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.
Who Took Part
It was open to people of any sex aged from 18 years up to 79 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: In good health with no underlying medical condition that, according to the Investigator, would place a subject at risk. Having given written informed consent.
The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: evidence of any malignancy; use of any tobacco product within 7 years of study entry; pregnant or lactating women.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
Because people in this TB-500 (Thymosin Beta-4 fragment) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The TB-500 (Thymosin Beta-4 fragment) group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received TB-500 (Thymosin Beta-4 fragment).
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2008-04 with completion listed for 2017-01-01.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length) in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the TB-500 (Thymosin Beta-4 fragment) compound page and the Thymosin Beta-4 (full length) compound page, all human trials.
Our Notes on the Compounds
TB-500 (Thymosin Beta-4 fragment): A synthetic fragment of thymosin beta-4 (43-aa parent, too large for oral use).
Thymosin Beta-4 (full length): The natural 43-amino-acid actin-binding peptide behind the TB-500 name; tested in human trials for eye, skin-wound and heart conditions.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.