NCT07069036已完成1 期
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of SEP-631 in Healthy Adult Volunteers
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Frequency of treatment emergent adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-631 in healthy adult volunteers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are able and willing to provide informed consent
- •Aged 18 to 60 years at the time of consent
- •Have a BMI within the range 18.5 to 32.0 kg/m2
- •In general good health
排除标准
- •Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
- •Have a history of any severe allergic reaction or anaphylaxis
- •Have clinically significant abnormalities on clinical laboratory results.
- •Participation in other clinical trials recently/currently
研究组 & 干预措施
Single Ascending Dose
Experimental
干预措施: Placebo (Other)
Multiple Ascending Dose
Experimental
干预措施: Placebo (Other)
Single Ascending Dose
Experimental
干预措施: SEP-631 (Drug)
Multiple Ascending Dose
Experimental
干预措施: SEP-631 (Drug)
Food Effect
Experimental
干预措施: SEP-631 (Drug)
结局指标
主要结局
Frequency of treatment emergent adverse events
时间窗: From enrollment to end of follow up visit, up to approximately 2 months
次要结局
- Plasma PK of SEP-631 after single and multiple doses(From enrollment to end of treatment period, up to approximately 14 days)
- Plasma PK of SEP-631 under fed and fasted conditions(From enrollment to end of treatment period, up to approximately 14 days)
研究者
研究点 (1)
Loading locations...
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