A Single-Center, Single-Dose, Placebo-Controlled, Randomized, Double-Blind, Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.
研究概览
简要总结
The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension. Including in this evaluation is the effect PL3994 has on blood pressure.
详细描述
Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. Current standards of care include intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. This study examines the effect of PL-3994 on patients with controlled hypertension who are receiving antihypertensive medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history
- •Subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history.
- •Subject must have a systolic blood pressure at screening between 100 and 150 mmHg, and diastolic blood pressure must not exceed 105 mmHg.
排除标准
- •Subject weight greater than 100 kg or less than 50 kg.
- •Any significant medical condition or abnormal safety laboratory results which, in the judgement of the Investigator would place the subject at significant risk.
研究组 & 干预措施
PL3994 Dose A
PL3994 Dose A
干预措施: PL3994 (Drug)
PL3994 Dose B
PL3994 Dose B
干预措施: PL3994 (Drug)
PL3994 Dose C
PL3994 Dose C
干预措施: PL3994 (Drug)
PL3994 Dose D
PL3994 Dose D
干预措施: PL3994 (Drug)
PL3994 Dose E
PL3994 Dose E
干预措施: PL3994 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.
时间窗: 24 hours
The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach. •Maximum concentration (Cmax) The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible.
Pharmacodynamics as Measured by cGMP Levels.
时间窗: 24 hours
Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible.
次要结局
未报告次要终点