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临床试验/NCT05291546
NCT05291546已完成1 期

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 (an Anti-REGN5381 Antibody and Reversal Agent) and REGN5381 (an NPR1 Agonist Antibody) When Administered Alone or in Sequence to Healthy Volunteers and Mildly Hypertensive Subjects

Regeneron Pharmaceuticals2 个研究点 分布在 2 个国家目标入组 93 人开始时间: 2022年4月13日最近更新:
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适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
93
试验地点
2
主要终点
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of the study is to:

• Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially.

The secondary objectives of the study are to:

  • Evaluate the ability of single intravenous (IV) doses of REGN9035 (compared to placebo) to reverse the acute hemodynamic effects of REGN5381
  • Evaluate the hemodynamic effects of single IV doses of REGN5381
  • Evaluate the persistence of the hemodynamic effects of single IV doses of REGN5381 and the reversal of REGN5381 effects by REGN9035 (compared to placebo)
  • Evaluate the pharmacokinetics of single IV doses of REGN5381 and REGN9035 administered alone or sequentially

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

  • •Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the screening visit.
  • •Normal or mildly elevated blood pressure as defined in the protocol.

排除标准

  • •History of unexplained syncope or autonomic dysfunction.
  • •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
  • •Protocol-defined risk factors for cardiovascular disease.
  • •Note: Other protocol defined inclusion / exclusion criteria apply

研究组 & 干预措施

Part A

Experimental

Single ascending dose (SAD) of REGN9035 or matching placebo given by intravenous (IV) administration.

干预措施: REGN9035 (Drug)

Part A

Experimental

Single ascending dose (SAD) of REGN9035 or matching placebo given by intravenous (IV) administration.

干预措施: Placebo (Other)

Part B

Experimental

Selected doses of REGN5381 or matching placebo given by IV administration followed by selected doses of REGN9035 and/or matching placebo via IV infusion

干预措施: REGN9035 (Drug)

Part B

Experimental

Selected doses of REGN5381 or matching placebo given by IV administration followed by selected doses of REGN9035 and/or matching placebo via IV infusion

干预措施: REGN5381 (Drug)

Part B

Experimental

Selected doses of REGN5381 or matching placebo given by IV administration followed by selected doses of REGN9035 and/or matching placebo via IV infusion

干预措施: Placebo (Other)

结局指标

主要结局

Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)

时间窗: Up to Day 162

次要结局

  • Absolute change from baseline in SBP(Through Day 36)
  • Maximum change in the mean SBP obtained after study drug administration(Up to Day 3)
  • Maximum change in the mean MAP obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (pre-REGN5381 administration) in the mean SV obtained after study drug administration(Up to Day 3)
  • Mean diastolic blood pressure (DBP) obtained after study drug administration(Up to Day 3)
  • Mean stroke volume (SV) obtained after study drug administration(Up to Day 3)
  • Absolute change in the mean MAP obtained after study drug administration(Up to Day 3)
  • Maximum change in the mean PP obtained after study drug administration(Up to Day 3)
  • Mean systolic blood pressure (SBP) obtained after study drug administration(Up to Day 3)
  • Mean pulse rate (PR) obtained after study drug administration(Up to Day 3)
  • Absolute change in the mean PP obtained after study drug administration(Up to Day 3)
  • Absolute change in the mean PR obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (pre-REGN administration) in the mean SV obtained after study drug administration(Up to Day 3)
  • Mean arterial pressure (MAP) obtained after study drug administration(Up to Day 3)
  • Mean pulse pressure (PP) obtained after study drug administration(Up to Day 3)
  • Absolute change in the mean DBP obtained after study drug administration(Up to Day 3)
  • Absolute change in the mean SBP obtained after study drug administration(Up to Day 3)
  • Absolute change in the mean SV obtained after study drug administration(Up to Day 3)
  • Maximum change in the mean DBP obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (post-REGN administration) in the mean DBP obtained after study drug administration(Up to Day 3)
  • Percent change from baseline (post-REN5381 administration) in the mean MAP obtained after study drug administration(Up to Day 3)
  • Percent change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration(Up to Day 3)
  • Maximum change in the mean SV obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (post-REGN administration) in the mean SBP obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (pre-REGN administration) in the mean DBP obtained after study drug administration(Up to Day 3)
  • Percent change from baseline (pre-REN5381 administration) in the mean MAP obtained after study drug administration(Up to Day 3)
  • Maximum change in the mean PR obtained after study drug administration(Up to Day 3)
  • Time to return to within 10% of baseline (pre-REGN5381) MAP(Up to approximately Day 162)
  • Percent change in the mean MAP obtained after study drug administration(Up to Day 3)
  • Percent change in the mean PR obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (post-REGN5381 administration) in the mean SBP obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (post-REGN5381 administration) in the mean MAP obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (post-REGN5381 administration) in the mean PP obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration(Up to Day 3)
  • Percent change from baseline (post-REN5381 administration) in the mean SBP obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (pre-REGN5381 administration) in the mean PR obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (pre-REGN administration) in the mean SBP obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (pre-REGN administration) in the mean MAP obtained after study drug administration(Up to Day 3)
  • Percent change in the mean SV obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (post-REGN administration) in the mean PP obtained after study drug administration(Up to Day 3)
  • Percent change from baseline (post-REN5381 administration) in the mean PP obtained after study drug administration(Up to Day 3)
  • Percent change in the mean SBP obtained after study drug administration(Up to Day 3)
  • Percent change in the mean DBP obtained after study drug administration(Up to Day 3)
  • Percent change in the mean PP obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (post-REGN5381 administration) in the mean DBP obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (post-REGN5381 administration) in the mean PR obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (post-REGN administration) in the mean MAP obtained after study drug administration(Up to Day 3)
  • Percent change from baseline (post-REN5381 administration) in the mean DBP obtained after study drug administration(Up to Day 3)
  • Time to return to within 10% of baseline (pre-REGN5381) PP(Up to approximately Day 162)
  • Percent change from baseline (post-REN5381 administration) in the mean SV obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (pre-REGN5381 administration) in the mean SBP obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (pre-REGN5381 administration) in the mean PP obtained after study drug administration(Up to Day 3)
  • Maximum change from baseline (pre-REGN administration) in the mean PR obtained after study drug administration(Up to Day 3)
  • Percent change from baseline (pre-REN5381 administration) in the mean DBP obtained after study drug administration(Up to Day 3)
  • Percent change from baseline (pre-REN5381 administration) in the mean PP obtained after study drug administration(Up to Day 3)
  • Time to return to within 10% of baseline (pre-REGN5381) SBP(Up to approximately Day 162)
  • DBP(Through Day 36)
  • MAP(Through Day 36)
  • Absolute change from baseline (pre-REGN5381 administration) in the mean DBP obtained after study drug administration(Up to Day 3)
  • Absolute change from baseline (pre-REGN5381 administration) in the mean MAP obtained after study drug administration(Up to Day 3)
  • Percent change from baseline (pre-REN5381 administration) in the mean SBP obtained after study drug administration(Up to Day 3)
  • Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) DBP obtained after study drug administration.(Baseline to Day 3)
  • Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) MAP obtained after study drug administration.(Baseline to Day 3)
  • PR(Through Day 36)
  • Absolute change from baseline in DBP(Through Day 36)
  • Absolute change from baseline in PP(Through Day 36)
  • Percent change from baseline in MAP(Through Day 36)
  • Percent change from baseline in PP(Through Day 36)
  • Percent change from baseline in PR(Through Day 36)
  • Percent change from baseline (pre-REN5381 administration) in the mean PR obtained after study drug administration(Up to Day 3)
  • Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PR obtained after study drug administration.(Baseline to Day 3)
  • Concentrations of total REGN9035(Up to Day 162)
  • Maximum change from baseline (pre-REGN administration) in the mean PP obtained after study drug administration(Up to Day 3)
  • Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SBP obtained after study drug administration.(Baseline to Day 3)
  • Time to return to within 10% of baseline (pre-REGN5381) DBP(Up to approximately Day 162)
  • Time to return to within 10% of baseline (pre-REGN5381) PR(Up to approximately Day 162)
  • Time to return to within 10% of baseline (pre-REGN5381) SV(Up to approximately Day 162)
  • Percent change from baseline (pre-REN5381 administration) in the mean SV obtained after study drug administration(Up to Day 3)
  • Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PP obtained after study drug administration.(Baseline to Day 3)
  • Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SV obtained after study drug administration.(Baseline to Day 3)
  • SBP(Through Day 36)
  • Absolute change from baseline in MAP(Through Day 36)
  • Absolute change from baseline in PR(Through Day 36)
  • PP(Through Day 36)
  • Percent change from baseline in SBP(Through Day 36)
  • Percent change from baseline in DBP(Through Day 36)
  • Concentrations of total REGN5381 over time(Up to Day 162)
  • Concentrations of total REGN9035 and/or total REGN5381(Up to Day 162)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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