跳至主要内容
临床试验/jRCT2031240676
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

Kyowa Kirin Co., Ltd.0 个研究点目标入组 144 人开始时间: 2025年4月17日最近更新:

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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