NCT06423352已完成1 期
A Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics, and Pharmacokinetics of Zilebesiran in Japanese Patients With Mild to Moderate Hypertension
Alnylam Pharmaceuticals3 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年6月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Frequency of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics (PD) and pharmacokinetics (PK) of zilebesiran in Japanese patients with mild to moderate hypertension.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin
- •Has mean systolic office blood pressure (SBP) of >130 and <=165 mmHg by automated office blood pressure measurement, after a minimum of 3 weeks of washout if taking hypertensive medication
- •Has 24-hour mean SBP ≥130 mmHg by ambulatory blood pressure monitoring (ABPM), without antihypertensive medication
排除标准
- •Has secondary hypertension, symptomatic orthostatic hypotension
- •Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN)
- •Has elevated serum potassium >5 mmol/L
- •Has estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m^2
- •Has received an investigational agent within the last 30 days
- •Has Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus or newly diagnosed Type 2 diabetes mellitus
- •Has history of intolerance to SC injection(s)
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will be administered a single dose of placebo.
干预措施: Placebo (Drug)
Zilebesiran
Experimental
Participants will be administered a single dose of zilebesiran.
干预措施: Zilebesiran (Drug)
结局指标
主要结局
Frequency of Adverse Events (AEs)
时间窗: Up to 12 months
Number of Participants With Adverse Events (AEs)
时间窗: Up to 12 months
An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
次要结局
- Change from Baseline at Month 3 and Month 6 in SBP and DBP Assessed by Office Blood Pressure(Baseline and Month 3 and Month 6)
- Percent Change from Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6(Baseline and Month 3 and Month 6)
- Pharmacokinetics of Zilebesiran and its Metabolite assessed by Plasma Concentration(Predose and up to 3 days postdose)
- Change from Baseline at Month 3 and Month 6 in 24-hour Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM)(Baseline and Month 3 and Month 6)
- Change From Baseline at Month 3 and Month 6 in SBP and DBP Assessed by OBP(Baseline and Month 3 and Month 6)
- Percent Change From Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6(Baseline and Month 3 and Month 6)
- Change From Baseline at Month 3 and Month 6 in 24-hour Mean SBP and DBP Assessed by ABPM(Baseline and Month 3 and Month 6)
- Maximum Plasma Concentration (Cmax) of Zilebesiran and Its Metabolite(Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.)
- Time to Maximum Plasma Concentration (Tmax) of Zilebesiran and Its Metabolite(Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.)
- Elimination Half-life (t1/2) of Zilebesiran and Its Metabolite(Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.)
- Area Under the Curve (AUClast) of Zilebesiran and Its Metabolite(Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.)
- Pooled Urine PK (fe) of Zilebesiran and Its Metabolite(Predose and 2 to 6, 6 to 12, and 12 to24 hours post-dose.)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
1 期
A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1)Myotonic Dystrophy Type 1 (DM1)NCT06185764Vertex Pharmaceuticals Incorporated47
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALN-TTRSC04 in Healthy SubjectsTransthyretin-Mediated AmyloidosisNCT05661916Alnylam Pharmaceuticals96
终止
1 期
Subcutaneous Administration of Teplizumab in Adults With Type 1 DiabetesType 1 Diabetes MellitusNCT01189422MacroGenics1
终止
1 期
A Study of an Investigational Drug, ALN-AAT, in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver DiseaseAntitrypsin Deficiency Liver DiseaseNCT02503683Alnylam Pharmaceuticals26
终止
2 期
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic SclerosisDiffuse Cutaneous Systemic SclerosisNCT02465437Corbus Pharmaceuticals Inc.42