TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TB-500, Placebo.
- Who it may be relevant to
- Registry conditions: Atherosclerotic Cardiovascular Diseases, Endothelial Dysfunction. Basic parameters: 40 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
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
- Drug TB-500
(thymosin beta 4 17-23 fragment - Drug Placebo
matching vehicle
Primary outcome measures
- incidence of treatment-emergent adverse events (TEAEs) [Time frame: 12 weeks]
- Incidence of serious adverse events (SAEs) [Time frame: 28 Days]
Secondary outcome measures (4)
- Brachial artery flow-mediated dilation (FMD) [Time frame: 8 weeks]
- High-sensitivity C-reactive protein (hs-CRP) [Time frame: 8 weeks]
- NT-proBNP [Time frame: 8 weeks]
- Exploratory vascular stiffness [Time frame: 8 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Shenzhen Hospital — Shenzhen
Identifiers
NCT: NCT07487363 · TB500-CV-101