NCT06205628进行中（未招募）1 期
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ADX-850 in Participants With Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Safety of ADX-850 in Participants with Hypertension
研究概览
简要总结
This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in participants with hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) between 18 and 35 kg/m2
- •Mild to moderate hypertension, mean of >130 and <165mmHg
- •No use of antihypertensive medication for a minimum of 2 weeks
- •Willing and able to comply with all study requirements
- •Willing to take irbesartan as concomitant ARB therapy (Part 2 only)
- •Must be a non-smoker for the duration of the study
排除标准
- •Secondary hypertension
- •Active malignancy and/or history of malignancy in the past 5 years
- •History of liver disease, Gilbert's syndrome, nonalcoholic steatohepatitis, severe steatosis, or abnormal liver function test results
- •Any active infection or acute illness
- •Major surgery or significant traumatic injury occurring within 3 months
- •Mean sitting diastolic BP (DBP) ≥110 mmHg
- •Orthostatic hypotension
- •Significant kidney disease or eGFR <60 mL/min/1.73m2
- •Abnormal potassium levels
- •History or presence of clinically significant ECG abnormalities
- •Treatment with another investigational product within 30 days prior to the first study drug administration
- •Pregnant, intend to become pregnant during the course of the study, or lactating
- •History of alcohol abuse
- •Night shift workers (regular working hours between 10:00 PM and 6:00 AM)
- •Any other significant medical history, such as major cardiovascular events or cancer
- •Known history of intolerance to ARB medication (Part 2 only)
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ADX-850
Experimental
干预措施: ADX-850 (Drug)
结局指标
主要结局
Safety of ADX-850 in Participants with Hypertension
时间窗: 365 days
Incidence, relationship and severity of adverse events and serious adverse events
次要结局
- Pharmacokinetics (PK) of ADX-850 - Maximum Concentration(8 days)
- Pharmacokinetics (PK) of ADX-850 - Time to Maximum Concentration(8 days)
- Pharmacokinetics (PK) of ADX-850 - Exposure(8 days)
- Pharmacodynamics (PD) of ADX-850 - Blood Pressure(365 days)
研究者
研究点 (3)
Loading locations...
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