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New treatment option for Atherosclerotic Cardiovascular Diseases
Official title TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
ClinicalTrials.gov ID: NCT07487363
What this study is testing
What is TB-500?
TB-500 is an investigational medicine, being studied as a potential treatment for atherosclerotic cardiovascular diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join 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...
- 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 likely can't join 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.
See the full eligibility 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.
- 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 treatment clinical study or receipt of an investigational product within 30 days (or 5 half-lives, whichever is longer) prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.