NCT07253324已完成1 期
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ENX-104 in Participants With Major Depressive Disorder With Anhedonia
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ENX-104 in participants with major depressive disorder with anhedonia (aMDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Biologically female participants (defined as assigned female at birth)
- •Of non-childbearing potential, defined as either permanently sterilized or postmenopausal and with a negative pregnancy test.
- •Of childbearing potential and willing to use both a highly effective method of contraception and a condom with any partner or remain abstinent, and with a negative pregnancy test
- •Not currently breastfeeding or lactating, and not intending to initiate breastfeeding during the course of study conduct
- •Biologically male participants (defined as assigned male at birth), if fertile must be willing to have a partner use a highly effective method of contraception and participant use a condom with any partner of childbearing potential, or remain abstinent
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-104
Experimental
干预措施: ENX-104 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events (TEAE)
时间窗: From Day 1 up to Day 21
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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