NCT04506645已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Two-Part Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Humans
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The primary objective of the study is to evaluate the safety and tolerability of single intravenous (IV) doses of REGN5381 in healthy normotensive and otherwise healthy hypertensive adults.
The secondary objectives of the study are:
- To evaluate the effect of single IV doses of REGN5381 on blood pressure (BP) and heart rate (HR) in healthy normotensive and otherwise healthy hypertensive adults
- To evaluate the effect of single IV doses of REGN5381 on cardiac stroke volume (SV)
- To evaluate the pharmacokinetics (PK) of single IV doses of REGN5381
- To evaluate the immunogenicity of single IV doses of REGN5381
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal or mildly elevated blood pressure as defined in the protocol
排除标准
- •History of cardiovascular disease as defined in the protocol
- •Protocol-defined risk factors for cardiovascular disease
- •History of unexplained syncope, autonomic dysfunction, or neurologic disease.
- •NOTE: Additional Inclusion / Exclusion criteria apply
研究组 & 干预措施
REGN5381
Experimental
Single dose REGN5381 administered via IV infusion
干预措施: REGN5381 (Drug)
Placebo
Other
Placebo matching single dose REGN 5381 administered via IV infusion
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Up to Day 78
次要结局
- Change from baseline in Pulse Pressure (PP)(Baseline to Day 4)
- Maximum change from baseline in MAP across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
- Maximum change from baseline in HR across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
- Maximum change from baseline in SV across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
- Change from baseline in the 24-hour mean SBP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose(Baseline to 24 hours postdose, 24 hours to 48 hours postdose, 48 hours to 72 hours postdose)
- Change from baseline in the 24-hour mean DBP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose(Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose)
- Change from baseline in Systolic Blood Pressure (SBP)(Up to Day 78)
- Change from baseline in Diastolic Blood Pressure (DBP)(Up to Day 78)
- Change from baseline in Mean Arterial Pressure (MAP)(Baseline to Day 4)
- Maximum change from baseline in PP across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
- Change from baseline in Heart Rate (HR)(Up to Day 78)
- Maximum change from baseline in SBP across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
- Change from baseline in Stroke Volume (SV)(Baseline to Day 4)
- Maximum change from baseline in DBP across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
- Change from baseline in the 24-hour mean MAP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose(Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose)
- Change from baseline in the 24-hour mean PP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose(Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose)
- Change from baseline in the 24-hour mean HR measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose(Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose)
- Concentrations of REGN5381 over time(Up to Day 78)
- Number of subjects who develop anti-drug antibodies (ADA) and titers(Up to Day 78)
- Percentage of subjects who develop anti-drug antibodies (ADA) and titers(Up to Day 78)
研究者
研究点 (2)
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