Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a multi-cohort, open-label, adaptive trial designed to evaluate the safety, tolerability, and biological effects of dietary supplements and other aging-targeted therapies.
Cohort 1 is a single-arm, open-label, intrapatient dose-escalation study evaluating the effects of escalating doses of spermidine in 10 participants. Patients will have baseline blood drawn and subsequently start daily administration of spermidine. They will receive capsules for three consecutive 28-day courses with escalating doses of 40mg, 120mg, and 400mg.
Subsequent cohorts will evaluate additional agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 75
- •Patients without known significant organ dysfunction, based on standard blood tests within the last year
排除标准
- •Patients taking any immunomodulatory medications that the investigator or treating physician believe may alter the immune response to the study agent (e.g. biologic antibodies, immunosuppressants)
- •Patients actively receiving any therapy that, in the determination of the investigator, may impact the effect of the study agent.
- •Patients who, in the opinion of the treating investigator, will not be able to follow treatment and defined follow-up
- •Pregnancy
研究组 & 干预措施
Spermidine
Participants will receive capsules for three consecutive 28-day courses with escalating doses of 40mg, 120mg, and 400mg.
干预措施: Spermidine (Dietary Supplement)
结局指标
主要结局
Safety and tolerability
时间窗: Baseline to Day 112
Assessment of toxicity of therapeutic intervention. Toxicity will be assessed through adverse event monitoring conducted at clinic visits or by phone, with adverse events evaluated and graded using CTCAE v5.0.
次要结局
- Change in systemic immune milieu(Baseline and approximately every 28 days through Day 112 (final study visit).)
- Change in systemic metabolic milieu(Baseline and approximately every 28 days through Day 112 (final study visit).)