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Trial · Interventional

RecruitingPhase 1/2Registry data

TB-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
2026202720282029
  1. Ph 1/2

    TBRIDGE-CV

    NCT07487363

    5 Feb 2026 to est. 17 Feb 2028

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.

  1. 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.

  2. Incidence of serious adverse events (SAEs)

    Time frame · 28 Days

Secondary outcomes(4)
  1. Brachial artery flow-mediated dilation (FMD)

    Time frame · 8 weeks

    Registry description

    Change from baseline in percent FMD measured by standardized ultrasound protocol

  2. High-sensitivity C-reactive protein (hs-CRP)

    Time frame · 8 weeks

    Registry description

    Change from baseline in hs-CRP concentration.

  3. NT-proBNP

    Time frame · 8 weeks

    Registry description

    Change from baseline in NT-proBNP concentration.

  4. 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
Inclusion Criteria: * Age 40-75 years, able to provide written informed consent. * Documented stable ASCVD (e.g., prior myocardial infarction \>6 months ago, prior coronary revascularization, stable angina with objective evidence of ischemia, or symptomatic peripheral artery disease). * On stable guideline-directed medical therapy (e.g., statin and antiplatelet therapy unless contraindicated) for at least 8 weeks before screening. * Resting systolic blood pressure \<160 mmHg and diastolic blood pressure \<100 mmHg (with or without therapy). * Able and willing to comply with study visits and procedures. Exclusion Criteria: * Acute coronary syndrome, stroke/transient ischemic attack, or coronary revascularization within 6 months before screening. * New York Heart Association (NYHA) class III-IV heart failure or left ventricular ejection fraction \<35%. * Clinically significant arrhythmia requiring recent hospitalization or unstable antiarrhythmic therapy. * Severe renal impairment (eGFR \<30 mL/min/1.73 m\^2) or end-stage renal disease. * Clinically significant hepatic impairment (e.g., Child-Pugh class B/C) or ALT/AST \>3x upper limit of normal at screening. * Active malignancy requiring systemic therapy (except adequately treated non-melanoma skin cancer) within the past 2 years. * Known autoimmune disease requiring systemic immunosuppression, or use of chronic systemic corticosteroids above physiologic replacement. * Pregnant or breastfeeding, or unwilling to use effective contraception during the study (if of childbearing potential). * Known hypersensitivity to peptide therapeutics or study formulation components. * Participation in another interventional clinical study or receipt of an investigational product within 30 days (or 5 half-lives, whichever is longer) prior to screening.

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