NCT06501586已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of SGB-3908 After a Single Administration in Healthy Subjects and Mildly Hypertensive Subjects
Suzhou Sanegene Bio Inc.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of SGB-3908 in healthy subjects and mildly hypertensive subjects. The study will be a single ascending dose (SAD) phase.
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
- 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
- •Has body mass index (BMI) ≥18 and ≤30 kg/m^2 and has bodyweight ≥ 50 kg;
- •Has Systolic blood pressure (SBP) ≥100 mmHg and ≤150 mmHg and diastolic blood pressure (DBP) ≥65 mmHg and ≤95 mmHg at screening;
排除标准
- •Has mental illness, liver and kidney disease, gastrointestinal disease, nervous system disease, or other related systemic diseases that affect the trial;
- •Has a history of hospitalization or other clinically significant diseases within 1 month before screening, major surgery within 6 months before screening, or other unstable conditions judged by the investigator;
- •Has a history of orthostatic hypotension or syncope;
- •Patients with clinically significant abnormalities confirmed by physical examination, 12-lead electrocardiogram, laboratory tests, etc., or those who meet any of the following conditions during screening need to be excluded:
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin higher than 1.5× upper limit of normal (ULN)
- •Serum creatinine (Cr) higher than ULN
- •Serum potassium higher than 5 mmol/L
- •QT/QTc interval prolongation during screening (QTcF>450 ms)
研究组 & 干预措施
SGB-3908
Experimental
干预措施: SGB-3908 (Drug)
SGB-3908-Matching placebo
Placebo Comparator
干预措施: SGB-3908-Matching placebo (Other)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: up to approximately 12 months
次要结局
- Maximum Observed Plasma Concentration (Cmax) of SGB-3908 and of Potential Metabolites(Up to Day 3)
- Number of Participants With Anti- SGB-3908 Antibodies(up to approximately 6 months)
- Change from Baseline in Blood Angiotensinogen (AGT) Level(up to approximately 12 months)
- Area Under the Concentration-time Curve (AUC) of SGB-3908 and of Potential Metabolites(Up to Day 3)
研究者
研究点 (1)
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