TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Atherosclerotic Cardiovascular Diseases, Endothelial Dysfunction
In brief
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
Key facts
- Study ID
- NCT07487363
- Run by
- Hudson Biotech
- People needed
- 80
- Starts
- 2026-02-05
- Expected to finish
- 2028-02-17
- Last updated by the study team
- 2026-03-23
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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