NCT07253246已完成1 期
A Two-Part, Single Ascending Dose and Positron Emission Tomography Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Receptor Occupancy After Single Oral Dose Administration of ENX-205 in Healthy Adult Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Part 1: Number of Participants with Treatment Emergent Adverse events
研究概览
简要总结
This is a two-part study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and receptor occupancy (RO) of ENX-205 in healthy adult participants in a double-blind placebo-controlled, single ascending dose (SAD) study (Part 1) and an open-label, single-dose, positron emission tomography (PET) study (Part 2).
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Part 2 of this study is open-label, and as such, randomization and blinding are not applicable.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Biologically female participants who are not pregnant, lactating, or breastfeeding
- •Of non-childbearing potential, defined as either permanently sterilized, and with a negative pregnancy test. OR
- •Part 1 only: Of childbearing potential and willing to comply with restrictions related to birth control, and with a negative pregnancy test.
- •Biologically male participants (defined as assigned male at birth), if fertile must be willing to comply with restrictions related to birth control. Moreover, male participants should refrain from sperm donation.
排除标准
- •Unable or unwilling to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, should not participate in the study
研究组 & 干预措施
ENX-205
Experimental
干预措施: ENX-205 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1: Number of Participants with Treatment Emergent Adverse events
时间窗: From Day 1 up to Day 10
次要结局
- Part 2: Number of Participants with Treatment Emergent Adverse events(From Day 1 up to Day 10)
研究者
研究点 (1)
Loading locations...
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