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
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