[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630414":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":11,"centralContacts":35,"locations":41,"responsibleParty":61,"collaborators":11,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":11,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":44,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Hudson Biotech","INDUSTRY",[8,15,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"TB-500 Low Dose","EXPERIMENTAL",null,[13,14],"Drug: TB-500","Drug: Placebo",{"label":16,"type":10,"description":11,"interventionNames":17},"TB-500 Medium Dose",[13,14],{"label":19,"type":10,"description":11,"interventionNames":20},"TB-500 High Dose",[13,14],{"label":22,"type":23,"description":11,"interventionNames":24},"Matching placebo","PLACEBO_COMPARATOR",[13,14],[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"DRUG","TB-500","(thymosin beta 4 17-23 fragment",[22,19,9,16],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"Placebo","matching vehicle",[22,19,9,16],[36],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Seni Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":51,"coordinates":52},"Point",[53,54],114.0683,22.54554,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":11,"email":60},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":62,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100630414","phase-1-tb-500-thymosin-beta-4-17-23-fragment-for-cardiovascular-biomarkers-in-stable-ascvd-100630414",false,"NCT07487363","TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD","A Phase 1\u002F2, 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","TBRIDGE-CV","Inclusion Criteria:\n\n* Age 40-75 years, able to provide written informed consent.\n* 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).\n* On stable guideline-directed medical therapy (e.g., statin and antiplatelet therapy unless contraindicated) for at least 8 weeks before screening.\n* Resting systolic blood pressure \\\u003C160 mmHg and diastolic blood pressure \\\u003C100 mmHg (with or without therapy).\n* Able and willing to comply with study visits and procedures.\n\nExclusion Criteria:\n\n* Acute coronary syndrome, stroke\u002Ftransient ischemic attack, or coronary revascularization within 6 months before screening.\n* New York Heart Association (NYHA) class III-IV heart failure or left ventricular ejection fraction \\\u003C35%.\n* Clinically significant arrhythmia requiring recent hospitalization or unstable antiarrhythmic therapy.\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2) or end-stage renal disease.\n* Clinically significant hepatic impairment (e.g., Child-Pugh class B\u002FC) or ALT\u002FAST \\>3x upper limit of normal at screening.\n* Active malignancy requiring systemic therapy (except adequately treated non-melanoma skin cancer) within the past 2 years.\n* Known autoimmune disease requiring systemic immunosuppression, or use of chronic systemic corticosteroids above physiologic replacement.\n* Pregnant or breastfeeding, or unwilling to use effective contraception during the study (if of childbearing potential).\n* Known hypersensitivity to peptide therapeutics or study formulation components.\n* 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.","ALL","40 Years","75 Years",{"count":75,"type":76},80,"ESTIMATED","INTERVENTIONAL",[79,80],"PHASE1","PHASE2","This fictional study is an example of a ClinicalTrials.gov-style record. It describes a Phase 1\u002F2 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",[83,84],"Atherosclerotic Cardiovascular Diseases","Endothelial Dysfunction",[28,86,87,88,89,90,91,92],"thymosin beta 4 fragment","vascular repair","endothelial function","flow-mediated dilation","inflammation","hs-CRP","atherosclerosis","2026-03-17",{"date":95,"type":96},"2026-03-23","ACTUAL",{"date":98,"type":96},"2026-02-05",{"date":100,"type":76},"2028-02-17",{"name":5,"class":6},1]