jRCT2031240676招募中不适用
A Phase 1, Placebo-Controlled, Double-Blind, Randomized, Single and Multiple Ascending-Dose Study of KK3910 in Healthy Volunteers and Patients with Essential Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 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
- 18age old over 至 80age old not(—)
- 性别
- All
入选标准
- •Voluntary consent to participate in this study must be given (in writing)
- •Japanese or non-Asian healthy men 18 to < 55 years at the time of informed consent (Japanese healthy men 65 to < 80 years for the elderly cohort)
- •BMI is within the specified range at screening
- •Voluntary consent to participate in this study must be given (in writing)
- •Japanese patients with essential hypertension, aged 18 to <65 years at the time of informed consent
- •BMI is within the specified range at screening
排除标准
- •History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
- •History of or current drug allergy
- •History of or current alcoholism or drug addiction
- •Smoking within the specified period
- •infection within the specified period
- •Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study
- •History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
- •History or of current drug allergy
- •History of or current alcoholism or drug addiction
- •Pregnant or breastfeeding patients, or patients willing to have a child during the study
- •Smoking within the specified period
- •infection within the specified period
- •Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study
结局指标
主要结局
-
Number of participants with adverse events
次要结局
未报告次要终点
研究者
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