2025-522379-26-00撤回2 期
Dose-finding exploratory study on Azithromycin on senescence in healthy volunteers
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Primary endpoints of this pilot study will be changes in 1) senescent cell abundance in the blood cells by p16INK4A evaluation; 2) other serum markers of aging/inflammaging
研究概览
简要总结
- To compare the three study arms with AZI in terms of the selected marker of senescence
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 60; ≤ 75 years
- •Normal organ function (hepatic and renal)
- •Established menopausal status for women (defined as no menses for 12 months)
- •Written informed consent
排除标准
- •At least one of these: • Evidence of an ongoing acute inflammatory event • Infectious disease in progress • Inflammatory bowel disease • AIDS • Active neoplasms • Active hematological diseases • Autoimmune/rheumatologic diseases • Diabetes • Systemic therapy with anti-inflammatory drugs (NSAIDs, steroids, aspirin) during the 30 days preceding enrolment • Therapy with immunomodulatory drugs: infliximab, adalimumab, golimumab, or etanercept for 90 days preceding enrolment • Subjects with documented congenital or acquired QT interval prolongation • Therapy with active substances that prolong the QT interval • Disturbances in the balance of electrolytes in cases of hypokalaemia and hypomagnesemia • Clinically relevant bradycardia, cardiac arrhythmia, or severe heart failure • Known allergy to AZI • Other experimental therapies in progress • Previous infection with C. difficile • Patient have recieved an investigational drug within 30 days before screening or within five half-lives of the investigational product
结局指标
主要结局
Primary endpoints of this pilot study will be changes in 1) senescent cell abundance in the blood cells by p16INK4A evaluation; 2) other serum markers of aging/inflammaging
Primary endpoints of this pilot study will be changes in 1) senescent cell abundance in the blood cells by p16INK4A evaluation; 2) other serum markers of aging/inflammaging
次要结局
- To determine the minimum effective dose
- To examine the safety
研究者
Alessio Nencioni
Scientific
IRCCS Ospedale Policlinico San Martino
研究点 (1)
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