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临床试验/jRCT2071260050
jRCT2071260050招募中不适用

A Phase 1b, Randomized, Participant- and Investigator- Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HJB647 Following Single Ascending Dose and Up-titration Multiple Dose Administration in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension (CHJB647A11101)

未提供0 个研究点目标入组 74 人开始时间: 待定
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
74

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

入排标准

年龄范围
18age old over 至 60age old under(—)
性别
All

入选标准

  • Japanese healthy participants with elevated blood pressure (Part 1) and patients with mild-to-moderate hypertension (Part 2)
  • Age: 18 to 55 years (Part 1) and 18 to 60 years (Part 2)
  • Body weight:
  • Male: >= 50.0 kg
  • Female: >= 45.0 kg
  • Body Mass Index (BMI): 18.0 to 30.0 kg/m2
  • Axillary body temperature: 35.0-37.5 celsius degree
  • Heart rate: 50-90 bpm
  • Blood pressure criteria are as follows:
  • Part 1: Healthy Participants with Elevated Blood Pressure Screening: Systolic Blood Pressure (SBP): 120 =< SBP =< 139 mmHg; Diastolic Blood Pressure (DBP): 60 =< DBP =< 94 mmHg Baseline (Day -1): SBP: 120 =< SBP =< 179 mmHg; DBP: 60 =< DBP =< 109 mmHg
  • Part 2: Patients with Hypertension Screening and Baseline (Day -1): SBP: 140 =< SBP =< 179 mmHg; DBP: 60 =< DBP =< 109 mmHg

排除标准

  • Significant illness, including infectious diseases that have not resolved within 30 days prior to baseline
  • History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants such as:
  • Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker.
  • History of familial long QT syndrome or known family history of Torsades de Pointes
  • Resting QT interval corrected by Fridericia's formula (QTcF) >= 450 msec (male) or >= 460 msec (female) at screening
  • At screening, hypokalemia or hypomagnesemia defined as potassium or magnesium values below the LLN on repeat measurement, or laboratory abnormalities indicating hypothyroidism, as determined at the discretion of the investigator
  • HbA1c >= 7.0% or LDL cholesterol >= 180 mg/dL or triglycerides >= 250 mg/dL
  • Use of any prescription drugs or herbal supplements within 4 weeks prior to initial dosing, and/or OTC medication or dietary supplements (vitamins included) within 2 weeks prior to initial dosing
  • Women of childbearing potential

研究者

发起方
未提供

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