jRCT2071240129招募中不适用
A Phase I, randomized, double-blind, placebo-controlled, comparative study to evaluate the safety, tolerability, and pharmacokinetics of repeated doses of TKT001-S in healthy Japanese adult males.
Seren Pharmaceuticals Inc.0 个研究点目标入组 24 人开始时间: 2025年5月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age 0month 0week old over 至 45age 0month 0week old not（—）
- 性别
- Male
入选标准
- •Japanese healthy males between the age of 20 to under 45 years
- •Those who the BMI between 18.5 kg/m^2to under 28.0 kg/m^2
排除标准
- •Those with illnesses that may affect the evaluation of the drug
- •History of hepatic, renal, or gastrointestinal or radiotherapy treatment that affects drug absorption
- •Those with a history or suspected history of alcohol or drug abuse
结局指标
主要结局
-
Phamacokinetics,Safety,Tolerability
次要结局
未报告次要终点
研究者
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