Current partner codePEPTIDESDE

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

Status

Recruiting

Phase

Phase 1 / Phase 2

Enrollment

80

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full detailed description

This example record models common ClinicalTrials.gov data elements for an interventional study. Design overview: Participants with stable ASCVD will be enrolled into three sequential dose cohorts. 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. Intervention period: Study drug is administered by trained clinic staff during scheduled on-site visits over an 8-week dosing period, followed by a 4-week safety follow-up. The specific dose levels are protocol-defined and are not provided in this public example. Assessments: Safety assessments include adverse events, concomitant medications, physical examinations, vital signs, clinical laboratory testing, and 12-lead ECG. Exploratory cardiovascular assessments include brachial artery flow-mediated dilation (FMD) and blood-based biomarkers of inflammation and cardiac stress. Escalation and oversight: An independent safety review committee evaluates cumulative safety data after each cohort completes early follow-up before enrollment begins in the next cohort.

Interventions

Treatment arms and agents.

DRUG

TB-500

(thymosin beta 4 17-23 fragment

DRUG

Placebo

matching vehicle

Timeline

From registration to results.

  1. First posted

    Mar 23, 2026

  2. Study start

    Feb 5, 2026

  3. Primary completion

    Feb 14, 2027

  4. Study completion

    Feb 17, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Mar 23, 2026

Outcomes

What the study measures.

Primary outcomes

incidence of treatment-emergent adverse events (TEAEs)

Time frame · 12 weeks

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

Incidence of serious adverse events (SAEs)

Time frame · 28 Days

Secondary outcomes

Brachial artery flow-mediated dilation (FMD)

Time frame · 8 weeks

Change from baseline in percent FMD measured by standardized ultrasound protocol

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

Time frame · 8 weeks

Change from baseline in hs-CRP concentration.

NT-proBNP

Time frame · 8 weeks

Change from baseline in NT-proBNP concentration.

Exploratory vascular stiffness

Time frame · 8 weeks

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

Eligibility

Who can take part.

Minimum age
40 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Thymosin Beta-4.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.