DRUG
TB-500
(thymosin beta 4 17-23 fragment
Status
Recruiting
Phase
Phase 1 / Phase 2
Enrollment
80
Locations
1
Results
Not posted
Publications
0
Study 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
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
(thymosin beta 4 17-23 fragment
DRUG
matching vehicle
Timeline
First posted
Mar 23, 2026
Study start
Feb 5, 2026
Primary completion
Feb 14, 2027
Study completion
Feb 17, 2028
Results posted
Not reported
Registry updated
Mar 23, 2026
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
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
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
China. Showing up to 24 locations stored in the fast local snapshot.
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Publications
No PMID-linked publications were present in this registry snapshot.
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