Trial · Interventional
RecruitingPhase 1/2Registry dataTB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
Short name TBRIDGE-CV
Overview
- Status
- Recruiting
- Phase
- Phase 1/2
- Enrollment
- 80 participants (estimated)
- Sponsor
- Hudson Biotech · Industry
- Design
- Randomized · Single masking
- Countries
1 country
China
- Start
- 5 Feb 2026
- Primary completion
- 14 Feb 2027 (estimated)
- Completion
- 17 Feb 2028 (estimated)
- First posted
- 23 Mar 2026
- Last update posted
- 23 Mar 2026
- Conditions
- Atherosclerotic Cardiovascular Diseases · Endothelial Dysfunction
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1/2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This fictional study is an example of a ClinicalTrials.gov-style record. It describes a Phase 1/2 trial evaluating the safety and tolerability of TB-500 (a 17-23 fragment of thymosin beta 4) versus placebo in adults with stable atherosclerotic cardiovascular disease (ASCVD). Exploratory endpoints assess vascular function and inflammation biomarkers
Interventions
- TB-500Drug
- PlaceboDrug
Arms4
Experimental
TB-500 Low Dose
Experimental
TB-500 Medium Dose
Experimental
TB-500 High Dose
Placebo comparator
Matching placebo
Primary outcomes2
Outcomes the sponsor listed as primary.
incidence of treatment-emergent adverse events (TEAEs)
Time frame · 12 weeks
Registry description
Proportion of participants with at least one TEAE/SAE; severity and relationship assessed by investigator.
Incidence of serious adverse events (SAEs)
Time frame · 28 Days
Secondary outcomes(4)
Brachial artery flow-mediated dilation (FMD)
Time frame · 8 weeks
Registry description
Change from baseline in percent FMD measured by standardized ultrasound protocol
High-sensitivity C-reactive protein (hs-CRP)
Time frame · 8 weeks
Registry description
Change from baseline in hs-CRP concentration.
NT-proBNP
Time frame · 8 weeks
Registry description
Change from baseline in NT-proBNP concentration.
Exploratory vascular stiffness
Time frame · 8 weeks
Registry description
Change from baseline in carotid-femoral pulse wave velocity (if available at site).
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 40 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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