NCT05716919进行中（未招募）1 期
A Phase I, Double Blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'Ivaltinostat' Capsule in Healthy Male Volunteers
Machaon Biotherapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年3月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Plasma Pharmacokinetic measures (Cmax, Cmax-ss)
研究概览
简要总结
A Phase I, Double blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'CG-745' Capsule in Healthy Male 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 - 4
Experimental
Cohort 1 : 50 mg/day Cohort 2 : 100 mg/day Cohort 3: 200mg/day [Cohort 4: 300mg/day: based on the result of Safety Review Meeting (SRM)]
干预措施: Ivaltinostat (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Plasma Pharmacokinetic measures (Cmax, Cmax-ss)
时间窗: up to 4 weeks
Plasma Pharmacokinetic measures (AUC max, AUCmax-ss)
时间窗: up to 4 weeks
次要结局
- The Number of Participants Who Experienced Serious or Non-Serious Adverse Events(Up to 4 weeks for each dosing cohort)
研究者
研究点 (1)
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