TB-500 (thymosin beta 4 fragment) to improve blood vessel function in people with stable atherosclerotic cardiovascular disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults 40–75 with documented stable ASCVD are enrolled into three sequential dose cohorts and randomized 3:1 to receive TB-500 or matching placebo. Masking is maintained for participants, care providers, investigators, and outcome assessors, and study drug is administered by trained clinic staff during on-site visits over an 8-week dosing period followed by a 4-week safety follow-up. Safety monitoring includes adverse events, concomitant medications, physical exams, vital signs, laboratory testing, and 12-lead ECGs, while exploratory endpoints include brachial artery flow-mediated dilation and blood biomarkers of inflammation and cardiac stress. An independent safety review committee reviews cumulative safety data after each cohort completes early follow-up before escalation to the next dose level.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.