jRCT2080223770未知1 期
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Dose of SCO-792 in the Healthy Adult Subjects.
试验速览
- 阶段
- 1 期
- 入组人数
- 36
- 主要终点
- Number of participants who experience at least 1 treatment-emergent adverse event
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, Double-Blind, Placebo-Controlled Study
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •# The participant is aged 20 to 45 years, inclusive, at the time of informed consent.
- •# The participant weights at least 50 kg and has a body mass index between 18.5 and 25.0 kg/m2 for Japanese.
排除标准
- •# The participant has received any investigational compound within 16 weeks (112 days) prior to the dose of randomized study drug.
- •# The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
结局指标
主要结局
Number of participants who experience at least 1 treatment-emergent adverse event
An adverse event is defined as any untoward or unintended sign, symptom, or illness that occurs with administration of a study drug regardless of whether it is causally related to the study drug.
次要结局
- AUC(0-tlqc)
- Tmax
- Cmax
研究者
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