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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
RECRUITINGincidence of treatment-emergent adverse events (TEAEs)
Proportion of participants with at least one TEAE/SAE; severity and relationship assessed by investigator.
Time frame: 12 weeks
Incidence of serious adverse events (SAEs)
Time frame: 28 Days
Brachial artery flow-mediated dilation (FMD)
Change from baseline in percent FMD measured by standardized ultrasound protocol
Time frame: 8 weeks
High-sensitivity C-reactive protein (hs-CRP)
Change from baseline in hs-CRP concentration.
Time frame: 8 weeks
NT-proBNP
Change from baseline in NT-proBNP concentration.
Time frame: 8 weeks
Exploratory vascular stiffness
Change from baseline in carotid-femoral pulse wave velocity (if available at site).
Time frame: 8 weeks
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