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

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test TB-500 (Thymosin Beta-4 fragment) for atherosclerosis, cardiovascular disease & high blood pressure.

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.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Matching placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

This example record models common ClinicalTrials.gov data elements for an interventional study.

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.

Assessments: Safety assessments include adverse events, concomitant medications, physical examinations, vital signs, clinical laboratory testing, and 12-lead ECG.

Who Took Part

80 planned participants were the target.

It was open to people of any sex aged from 40 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: acute coronary syndrome, stroke/transient ischemic attack, or coronary revascularization within 6 months before 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.

How the Study Was Run

The set-up was randomized, sequential and single-blind.

Random assignment meant chance, not the researchers, decided who got TB-500 (Thymosin Beta-4 fragment) and who got the comparison, which limits bias.

In this single-blind TB-500 (Thymosin Beta-4 fragment) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2026-02-05 with completion listed for 2027-02-14.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): incidence of treatment-emergent adverse events (TEAEs) (time frame: 12 weeks). Incidence of serious adverse events (SAEs) (time frame: 28 Days).

It also tracked 4 secondary outcomes, for example Brachial artery flow-mediated dilation (FMD), High-sensitivity C-reactive protein (hs-CRP), NT-proBNP and Exploratory vascular stiffness.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of TB-500 (Thymosin Beta-4 fragment) in 80 people with atherosclerosis, cardiovascular disease & high blood pressure.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the TB-500 (Thymosin Beta-4 fragment) compound page, Atherosclerosis, cardiovascular disease & high blood pressure research.