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

This example record models common ClinicalTrials.gov data elements for an interventional study. Design overview: Participants with stable ASCVD will be enrolled into three sequential dose cohorts. Within each cohort, participants are randomized in a 3:1 ratio to TB-500 or matching placebo. Masking is maintained for participants, care providers, investigators, and outcome assessors. Intervention period: Study drug is administered by trained clinic staff during scheduled on-site visits over an 8-week dosing period, followed by a 4-week safety follow-up. The specific dose levels are protocol-defined and are not provided in this public example. Assessments: Safety assessments include adverse events, concomitant medications, physical examinations, vital signs, clinical laboratory testing, and 12-lead ECG. Exploratory cardiovascular assessments include brachial artery flow-mediated dilation (FMD) and blood-based biomarkers of inflammation and cardiac stress. Escalation and oversight: An independent safety review committee evaluates cumulative safety data after each cohort completes early follow-up before enrollment begins in the next cohort.

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.