RecruitingPhase 1Phase 2NCT07487363

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

A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of TB-500 (Thymosin Beta 4 17-23 Fragment) in Adults With Stable Atherosclerotic Cardiovascular Disease to Evaluate Safety, Tolerability, Pharmacokinetics, and Exploratory Cardiovascular Biomarkers

Sponsor

Hudson Biotech

Enrollment

80 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

Endothelial Dysfunction Atherosclerotic Cardiovascular Diseases

Summary

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

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria10

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.

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