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

NCT07487363 | Recruiting Phase 1 DMC

• 1 other identifier: TB500-CV-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atherosclerotic Cardiovascular Diseases; Endothelial Dysfunction

Keywords

TB-500; thymosin beta 4 fragment; vascular repair; endothelial function; flow-mediated dilation; inflammation; hs-CRP; atherosclerosis

Outcome Measures

Primary Outcomes (2)

• incidence of treatment-emergent adverse events (TEAEs)

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

  12 weeks

• Incidence of serious adverse events (SAEs)

  28 Days

Secondary Outcomes (4)

• Brachial artery flow-mediated dilation (FMD)

  8 weeks

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

  8 weeks

• NT-proBNP

  8 weeks

• Exploratory vascular stiffness

  8 weeks

Study Arms (4)

TB-500 Low Dose

EXPERIMENTAL

Drug: TB-500; Drug: Placebo

TB-500 Medium Dose

EXPERIMENTAL

Drug: TB-500; Drug: Placebo

TB-500 High Dose

EXPERIMENTAL

Drug: TB-500; Drug: Placebo

Matching placebo

PLACEBO COMPARATOR

Drug: TB-500; Drug: Placebo

Interventions

TB-500 DRUG

(thymosin beta 4 17-23 fragment

Matching placebo; TB-500 High Dose; TB-500 Low Dose; TB-500 Medium Dose

Placebo DRUG

matching vehicle

Matching placebo; TB-500 High Dose; TB-500 Low Dose; TB-500 Medium Dose

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hudson Biotech: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

MeSH Terms

Conditions

Inflammation; Atherosclerosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Seni Lu, Phd

CONTACT

+86 13076790030; Seni-Lu@beijing-biotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: TB-500 and placebo are identical in appearance/packaging. Randomization codes are maintained by an unblinded pharmacist or designee; participants, treating clinicians, investigators, and outcome assessors remain blinded.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three sequential dose cohorts with a randomized, parallel placebo control within each cohort (3:1 TB-500:placebo). Dose escalation proceeds after safety review.

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 23, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 17, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CN (1)