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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
TB-500 and placebo are identical in appearance/packaging. Randomization codes are maintained by an unblinded pharmacist or designee; participants, treating clinicians, investigators, and outcome assessors remain blinded.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
incidence of treatment-emergent adverse events (TEAEs)
时间窗: 12 weeks
Proportion of participants with at least one TEAE/SAE; severity and relationship assessed by investigator.
Incidence of serious adverse events (SAEs)
时间窗: 28 Days
次要结局
- Brachial artery flow-mediated dilation (FMD)(8 weeks)
- High-sensitivity C-reactive protein (hs-CRP)(8 weeks)
- NT-proBNP(8 weeks)
- Exploratory vascular stiffness(8 weeks)