A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Features of a Single Subcutaneous Administration of IBI3016 in Patients With Mild or Moderate Hypertension in China
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety indicators-Number of Participants with Adverse Events (AEs)
研究概览
简要总结
A Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamic characteristics of a single subcutaneous dose of IBI3016 in Chinese patients with mild to moderate hypertension.
详细描述
This study is a double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamics of a single subcutaneous dose of IBI3016 in Chinese patients with mild to moderate hypertension. The study plans to enroll approximately 30 subjects with mild to moderate hypertension (msSBP ≥140 mmHg and ≥170 mmHg) receiving antihypertensive medication. Eligible subjects will be randomly assigned in a 1:1:1:1:1 ratio to either the IBI3016 dose 1 group, the IBI3016 dose 2 group, the IBI3016 dose 3 group, the IBI3016 dose 4 group, or the placebo group. The entire trial period includes a 6-week screening period, a 12-week safety follow-up period, and an extended follow-up period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Males or females aged 18 to 75 years. 3 Diagnosed primary hypertension who have not been taking anti-hypertensive medication within 4 weeks prior to informed consent.
- •4.Mean sitting SBP ≥140 mmHg and < 170 mmHg measured by OBPM. 5.Participants able to understand and comply with study procedures.
排除标准
- •Known history of secondary hypertension.
- •Orthostatic hypotension.
- •Laboratory parameter assessments outside of range at screening：
- •Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 2× Upper Limit of Normal (ULN)
- •Total Bilirubin > 1.5× ULN
- •International Normalized Ratio (INR) > 2.0
- •Serum Potassium > 5 mmol/L
- •Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL/min/1.73m²
- •QTcF > 480 ms
- •Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
- •Current or history of intolerance to ACEi and/or ARBs.
- •Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening, or a previous diagnosis of decompensated heart failure or New York Heart Association (NYHA) grade III or IV heart failure.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
IBI3016 dose 3
subcutaneous injection
干预措施: IBI3016 (Drug)
IBI3016 dose 1
subcutaneous injection
干预措施: IBI3016 (Drug)
IBI3016 dose 2
subcutaneous injection
干预措施: IBI3016 (Drug)
IBI3016 dose 4
subcutaneous injection
干预措施: IBI3016 (Drug)
placebo
subcutaneous injection
干预措施: Placebo (Other)
结局指标
主要结局
Safety indicators-Number of Participants with Adverse Events (AEs)
时间窗: from baseline to week 12
up to approximately 12 months
次要结局
- Plasma pharmacokinetic parameters- half-life(from baseline to week 12)
- Urinary pharmacokinetic parameters-Fraction Excreted(Fe)(from baseline to week 12)
- Urinary pharmacokinetic parameters-Renal Clearance rate (CLr)(from baseline to week 12)
- Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline after drug administration by mean sitting blood pressure (msBP)(from baseline to week 12)
- Plasma pharmacokinetic parameters-peak concentration（Cmax）(from baseline to week 12)
- Urinary pharmacokinetic parameters-drug amount excreted(Ae)(from baseline to week 12)
- Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline after drug administration by 24-hour ambulatory blood pressure monitoring(from baseline to week 12)
- Plasma pharmacokinetic parameters-Time to peak concentration（Tmax）(from baseline to week 12)
- Plasma pharmacokinetic parameters-AUC（0-last）(from baseline to week 12)
- Plasma pharmacokinetic parameters- AUC（0-inf）(from baseline to week 12)
- Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline after drug administration by home blood pressure monitoring (HBPM)(from baseline to week 12)