Atherosclerotic Cardiovascular DiseasesPhase 1/2TBRIDGE-CVNCT07487363
TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
A Phase 1/2 study testing TB-500 in people with Atherosclerotic Cardiovascular Diseases and Endothelial Dysfunction, run by Hudson Biotech at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Diseases, Endothelial Dysfunction
- What is being tested?
- TB-500
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2026to 17 Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
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
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
Read the 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.
- Being tested
- TB-500, Placebo
- Keywords
- TB-500, thymosin beta 4 fragment, vascular repair, endothelial function, flow-mediated dilation, inflammation, hs-CRP, atherosclerosis
- Medical subject headings
- Inflammation, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB-500Drug
(thymosin beta 4 17-23 fragment
PlaceboDrug
matching vehicle
| Study group | Role | What they receive |
|---|---|---|
| TB-500 Low Dose | Experimental | Not described Receives: Drug: TB-500; Drug: Placebo |
| TB-500 Medium Dose | Experimental | Not described Receives: Drug: TB-500; Drug: Placebo |
| TB-500 High Dose | Experimental | Not described Receives: Drug: TB-500; Drug: Placebo |
| Matching placebo | Placebo comparator | Not described Receives: Drug: TB-500; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of treatment-emergent adverse events (TEAEs)
Proportion of participants with at least one TEAE/SAE; severity and relationship assessed by investigator.
Measured: 12 weeks
Incidence of serious adverse events (SAEs)
Measured: 28 Days
Secondary outcomes (4)
Brachial artery flow-mediated dilation (FMD)
Change from baseline in percent FMD measured by standardized ultrasound protocol
Measured: 8 weeks
High-sensitivity C-reactive protein (hs-CRP)
Change from baseline in hs-CRP concentration.
Measured: 8 weeks
NT-proBNP
Change from baseline in NT-proBNP concentration.
Measured: 8 weeks
Exploratory vascular stiffness
Change from baseline in carotid-femoral pulse wave velocity (if available at site).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start5 Feb 2026
- Primary completion14 Feb 2027 (estimated)
- Study completion17 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Three sequential dose cohorts with a randomized, parallel placebo control within each cohort (3:1 TB-500:placebo). Dose escalation proceeds after safety review.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hudson Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487363
- Sponsor's protocol ID
- TB500-CV-101
- Acronym
- TBRIDGE-CV
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07487363
- Acronym / sponsor ID
- TBRIDGE-CV / TB500-CV-101
- Keywords
- TB-500, thymosin beta 4 fragment, vascular repair, endothelial function, flow-mediated dilation, inflammation, hs-CRP, atherosclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hudson BiotechIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 17 Feb 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Three sequential dose cohorts with a randomized, parallel placebo control within each cohort (3:1 TB-500:placebo). Dose escalation proceeds after safety review.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB-500(thymosin beta 4 17-23 fragment | Drug | Matching placebo, TB-500 High Dose, TB-500 Low Dose, TB-500 Medium Dose |
| Placebomatching vehicle | Drug | Matching placebo, TB-500 High Dose, TB-500 Low Dose, TB-500 Medium Dose |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TB-500 in people with Atherosclerotic Cardiovascular Diseases and Endothelial Dysfunction, run by Hudson Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seni Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of treatment-emergent adverse events (TEAEs) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.