TB-500 (thymosin beta 4 fragment) to improve blood vessel function in people with stable atherosclerotic cardiovascular disease
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
This trial will test whether TB-500 (a fragment of thymosin beta 4) is safe and can improve blood vessel function in adults aged 40–75 with stable ASCVD.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Hudson Biotech Industry-sponsored |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07487363 on ClinicalTrials.gov |
What this trial studies
Adults 40–75 with documented stable ASCVD are enrolled into three sequential dose cohorts and randomized 3:1 to receive TB-500 or matching placebo. Masking is maintained for participants, care providers, investigators, and outcome assessors, and study drug is administered by trained clinic staff during on-site visits over an 8-week dosing period followed by a 4-week safety follow-up. Safety monitoring includes adverse events, concomitant medications, physical exams, vital signs, laboratory testing, and 12-lead ECGs, while exploratory endpoints include brachial artery flow-mediated dilation and blood biomarkers of inflammation and cardiac stress. An independent safety review committee reviews cumulative safety data after each cohort completes early follow-up before escalation to the next dose level.
Who should consider this trial
Good fit: Adults aged 40–75 with documented stable ASCVD who are on stable guideline-directed medical therapy and can attend scheduled on-site visits are the intended participants.
Not a fit: People with recent acute coronary syndrome, recent stroke or revascularization, advanced heart failure, significant unstable arrhythmias, severe renal impairment, or who cannot comply with on-site dosing and follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, TB-500 could improve endothelial function and reduce inflammation markers, which might lower cardiovascular risk in people with stable ASCVD.
How similar studies have performed: Preclinical data and limited early human work on thymosin beta 4 fragments suggest vascular reparative effects, but randomized clinical data in stable ASCVD are currently limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shenzhen, Guangdong
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Seni Lu, Phd
- Email: Seni-Lu@beijing-biotech.com
- Phone: +86 13076790030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.