NCT07279636已完成1 期
A Randomized, Double-blind, Placebo-Controlled, Dose-Escalation, Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Oral Administration of Alpha-0261 Tablets in Adult Healthy Participants
AlphaMol Science Ltd. (Shanghai)1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年7月21日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 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, and pharmacodynamics of Alpha-0261 tablets after single oral administration 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 18 and ≤ 55, male or female
- •Weight: ≥ 50 kg for males, ≥ 45 kg for females; 19 kg/m2 ≤ body mass index (BMI) ≤ 28 kg/m2
- •In general good health
排除标准
- •Have a history of any severe allergic reaction or anaphylaxis
- •Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol
- •Have clinically significant abnormalities on clinical laboratory results
研究组 & 干预措施
Single Ascending Dose
Experimental
干预措施: Alpha-0261 (Drug)
Single Ascending Dose (placebo)
Placebo Comparator
干预措施: Placebo (Other)
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 1 week
次要结局
- Plasma PK of Alpha-0261 after single dose(From enrollment to end of treatment period, up to approximately 7 days)
研究者
研究点 (1)
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