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

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 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

Study Overview

• Status: Recruiting
• Conditions: Endothelial Dysfunction; Atherosclerotic Cardiovascular Diseases
• Intervention / Treatment: Drug: TB-500; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Seni Lu, Phd; Phone Number: +86 13076790030; Email: Seni-Lu@beijing-biotech.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518036
      • Recruiting
      • Peking University Shenzhen Hospital
      • Contact: Zhen J Peng, Phd; Phone Number: +86 13076790039; Email: Zhen-Peng@beijing-biotech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matching placebo	Drug: TB-500; (thymosin beta 4 17-23 fragment; Drug: Placebo; matching vehicle
Experimental: TB-500 Low Dose	Drug: TB-500; (thymosin beta 4 17-23 fragment; Drug: Placebo; matching vehicle
Experimental: TB-500 Medium Dose	Drug: TB-500; (thymosin beta 4 17-23 fragment; Drug: Placebo; matching vehicle
Experimental: TB-500 High Dose	Drug: TB-500; (thymosin beta 4 17-23 fragment; Drug: Placebo; matching vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brachial artery flow-mediated dilation (FMD)	Change from baseline in percent FMD measured by standardized ultrasound protocol	8 weeks
High-sensitivity C-reactive protein (hs-CRP)	Change from baseline in hs-CRP concentration.	8 weeks
NT-proBNP	Change from baseline in NT-proBNP concentration.	8 weeks
Exploratory vascular stiffness	Change from baseline in carotid-femoral pulse wave velocity (if available at site).	8 weeks

Collaborators and Investigators

• Sponsor: Hudson Biotech

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 17, 2028

Study Registration Dates

• First Submitted: March 14, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: atherosclerosis; inflammation; flow-mediated dilation; endothelial function; hs-CRP; TB-500; thymosin beta 4 fragment; vascular repair
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Signs and Symptoms; Inflammation; Atherosclerosis
• Other Study ID Numbers: TB500-CV-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No