TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
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
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
Treatments tested in this trial
- TB-500
- Placebo
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov