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

ConditionsAtherosclerotic Cardiovascular DiseasesEndothelial Dysfunction
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorHudson Biotech

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 m²) or end-stage renal disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • TB-500

    Drug

    (thymosin beta 4 17-23 fragment

  • Placebo

    Drug

    matching vehicle

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: TB-500 Low DoseExperimental treatment 2 interventions
Group B: TB-500 Medium DoseExperimental treatment 2 interventions
Group C: TB-500 High DoseExperimental treatment 2 interventions
Group D: Matching placeboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

incidence of treatment-emergent adverse events (TEAEs)

Proportion of participants with at least one TEAE/SAE; severity and relationship assessed by investigator.

Time frame
12 weeks
2

Incidence of serious adverse events (SAEs)

Time frame
28 Days

Secondary outcomes

1

Brachial artery flow-mediated dilation (FMD)

Change from baseline in percent FMD measured by standardized ultrasound protocol

Time frame
8 weeks
2

High-sensitivity C-reactive protein (hs-CRP)

Change from baseline in hs-CRP concentration.

Time frame
8 weeks
3

NT-proBNP

Change from baseline in NT-proBNP concentration.

Time frame
8 weeks
4

Exploratory vascular stiffness

Change from baseline in carotid-femoral pulse wave velocity (if available at site).

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hudson Biotech

Lead sponsor

Source ClinicalTrials.gov
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