NCT07219511招募中1 期
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Vasa Therapeutics27 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年11月4日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 27
- 主要终点
- Participant incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all inclusion criteria to be eligible for trial participation.
- •Males or females ≥ 50 years of age at the time of signing the informed consent.
- •Diagnosis of HFpEF as defined by European Society of Cardiology or American College of Cardiology/American Heart Association criteria
- •NYHA Functional Class II or III
- •LVEF ≥ 50% demonstrated by echocardiography (ECHO) performed at Screening with evidence of heart failure
- •Elevated NT-proBNP at Screening
- •NordicPRO-C6™ ≥ 11 ng/mL at Screening.
- •Stable dose of all concomitant HF medications for at least 4 weeks prior to Screening.
- •Body weight of at least 110 lbs (50 kg) and body mass index (BMI) within the range ≥ 18 to < 45 kg/m
- •Males must agree to the contraception requirements and females must be of non-childbearing potential
- •Able to understand and willing to sign a written informed consent form (ICF).
- •Willing and able to comply with trial procedures and restrictions listed in the ICF and in this protocol.
排除标准
- •Female trial participant who is pregnant or breastfeeding.
- •Known hypersensitivity to VS-
- •Cardiovascular disease other than HFpEF
- •Active intercurrent illness such as acute bacterial or viral infection.
- •History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation.
- •Active chronic viral infection such as Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) at Screening.
- •Acute decompensated HF within 30 days of Screening
- •Lung disease within 12 months prior to Screening
- •History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
- •History of any other condition including psychiatric disorders that, in the opinion of the PI, may preclude the participant from following and completing the protocol.
- •Have participated within the last 6 months in a clinical study involving an investigational product.
- •Any other reason which, in the opinion of the PI, would prevent the participant from participating in the trial.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
High Dose VS-041
Experimental
干预措施: VS-041 (Drug)
Low Dose VS-041
Experimental
干预措施: VS-041 (Drug)
结局指标
主要结局
Participant incidence of treatment-emergent adverse events (TEAEs)
时间窗: From Baseline to Day 28
To evaluate the safety and tolerability of VS-041 in participants with HFpEF
Change from baseline over time in serum NordicPRO-C6
时间窗: From Baseline to Day 28
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Change from baseline over time in serum endotrophin
时间窗: From Baseline to Day 28
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Change from baseline over time in serum NT-proBNP
时间窗: From Baseline to Day 28
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
次要结局
- Pharmacokinetic profiles and parameters derived for VS-041 - Tmax(From Baseline to Day 28)
- Pharmacokinetic profiles and parameters derived for VS-041 - Cmax(From Baseline to Day 28)
研究者
研究点 (27)
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