Actively Recruiting

Phase 1
Phase 2
Age: 40Years - 75Years
All Genders
NCT07487363

TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD

Led by Hudson Biotech · Updated on 2026-03-23

80

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 to 75 years and able to provide written informed consent
  • Documented stable atherosclerotic cardiovascular disease (ASCVD), such as previous myocardial infarction over 6 months ago, prior coronary revascularization, stable angina with evidence of ischemia, or symptomatic peripheral artery disease
  • On stable guideline-directed medical therapy, including statins and antiplatelet therapy unless contraindicated, for at least 8 weeks before screening
  • Resting systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 100 mmHg, with or without therapy
  • Able and willing to comply with study visits and procedures
Not Eligible

You will not qualify if you...

  • Acute coronary syndrome, stroke, transient ischemic attack, or coronary revascularization within 6 months before screening
  • New York Heart Association class III-IV heart failure or left ventricular ejection fraction less than 35%
  • Clinically significant arrhythmia requiring recent hospitalization or unstable antiarrhythmic therapy
  • Severe renal impairment with eGFR less than 30 mL/min/1.73 m² or end-stage renal disease
  • Clinically significant liver impairment such as Child-Pugh class B or C or ALT/AST greater than 3 times the upper limit of normal at screening
  • Active cancer requiring systemic treatment within the past 2 years, except treated non-melanoma skin cancer
  • Known autoimmune disease needing systemic immunosuppression or use of high-dose systemic corticosteroids
  • Pregnant or breastfeeding, or unwilling to use effective contraception if able to become pregnant
  • Known allergy to peptide therapies or study formulation components
  • Participation in another interventional clinical trial or receipt of an investigational product within 30 days or 5 half-lives before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China, 518036

Actively Recruiting

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Research Team

S

Seni Lu, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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