NCT04418297终止1 期
A Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Celltrion
- 入组人数
- 23
- 试验地点
- 11
- 主要终点
- Incidence and severity of treatment-emergent adverse events and their relationship to the investigational product
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment, ascending dose study in subjects with obstructive HCM aged 18-70 years. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 to 70 years, inclusive at Screening
- •Has established diagnosis of HCM defined by standard criteria as a maximal left ventricular wall thickness ≥15 mm at initial diagnosis in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed or ≥13 mm if the subject has a family history of HCM
- •Has LVOT gradient ≥30 mmHg at rest or LVOT gradient ≥50 mmHg with Valsalva maneuver, due to SAM
排除标准
- •Known infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis or Noonan syndrome with LV hypertrophy
- •History of persistent atrial fibrillation prior to Screening or Baseline
- •History of paroxysmal atrial fibrillation requiring treatment (e.g., anti-coagulation and/or antiarrhythmic therapy) within 3 months prior to Screening
- •Recently treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation) within 6 months prior to Screening or plans to have either of these treatments during the study
- •Systolic heart failure with ejection fraction <55% or heart failure symptoms of NYHA Class IV
- •QTcF >480 msec at Screening or Baseline
- •Presence of diseases classified as significant by the Investigator at Screening or Baseline, including the following but not limited to:
- •Diabetes mellitus requiring treatment
- •Moderate or severe renal insufficiency or renal insufficiency with estimated glomerular filtration rate <70 mL/min/1.73m2
- •Concomitant use of Disopyramide or Ranolazine within at least 7 days or 5 half-lives (whichever is longer) prior to Screening
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
CT-G20
Experimental
干预措施: CT-G20 (Drug)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events and their relationship to the investigational product
时间窗: 12 days
次要结局
未报告次要终点
研究者
研究点 (11)
Loading locations...
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