ACTRN12623000023651招募中1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-00163 in Healthy Subjects and Subjects with Mild Hypertension
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 56
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
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 72 Years（—）
- 性别
- All
入选标准
- •1.Healthy males or females aged 18 to 60 years, inclusive, at the time of informed consent.(Part A only).
- •2. Males or females aged 18 to 72 years, inclusive, at the time of informed consent (Part B only).
- •3.Body mass index (BMI) >= 18 and <= 32 kg/m2 and body weight >50 kg (Part A only)..
- •4.Body mass index (BMI) =18 and =35 kg/m2 and body weight >50 kg (Part B only).
- •5.Triplicate 12-lead electrocardiogram (ECG) after >5 minutes resting without clinically significant findings at screening and Day -1.
排除标准
- •1. History of hypotension or orthostatic hypotension.
- •2. History of syncope.
- •3. SBP <90 mmHg or DBP <60 mm Hg at screening (Part A only).
- •4. Clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening.
- •5.History or presence of type 1 or type 2 diabetes mellitus at screening (Fasting blood glucose >7.0 mmol/L or HBA1c >6.5%).
- •6. Any liver function panel analyte value > 1.2 ×upper limits of normal (ULN) at
研究者
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