NCT07270783进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of D-2570 Tablets in Healthy Subjects
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
Double Blinded Healthy Volunteer study evaluating D-2570 against placebo in various doses.
详细描述
Double blind study evaluating the safety, tolerability and PK data of D-2570/placebo in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer subjects meeting eligibility criteria
排除标准
- •Subjects with ongoing or history of disease or co-morbidities as assessed by Principal Investigator which would make them ineligible for the study
- •Subjects with a history of drug and alcohol abuse
- •Subjects taking medications, over the counter or herbal remedies
研究组 & 干预措施
Cohort 3 D-2570/Placebo
Experimental
干预措施: Placebo (Drug)
Cohort 1 D-2570/Placebo
Experimental
干预措施: D-2570 (Drug)
Cohort 3 D-2570/Placebo
Experimental
干预措施: D-2570 (Drug)
Cohort 2 D-2570/Placebo
Experimental
干预措施: D-2570 (Drug)
Cohort 1 D-2570/Placebo
Experimental
干预措施: Placebo (Drug)
Cohort 2 D-2570/Placebo
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: From Informed Consent through study completion, an average of 48 days
Incidence of adverse events
Result of Pharmacokinetic endpoint
时间窗: From Randomization through study completion, an average of 20 days
Tmax
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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