NCT06347159进行中（未招募）2 期
An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults With Hypertrophic Cardiomyopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 79
- 试验地点
- 29
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (oHCM) and as multiple doses in adults with obstructive or nonobstructive hypertrophic cardiomyopathy (nHCM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or nonpregnant female, age ≥18 years to <85 years.
- •Body mass index (BMI) ≥18 to <35 kg/m2; weight ≥50 kg at Screening (BMI ≥ 18 to < 40 kg/m2 is permitted for participants < 50 years).
- •Diagnosed with hypertrophic cardiomyopathy at the time of Screening consistent with current American College of Cardiology Foundation/American Heart Association Guidelines.
- •LVOT peak gradient ≥ 50 mmHg measured at rest or during the Valsalva maneuver as determined by echocardiography at Screening (Part A, B and D oHCM only).
- •LVOT peak gradient < 30 mmHg measured at rest and < 50 mmHg measured during the Valsalva maneuver as determined by echocardiography at Screening (Part C and D nHCM only).
- •Documented left ventricular ejection fraction (LVEF) ≥ 0.60 at Screening.
- •New York Heart Association (NYHA) Classification II-III at Screening.
- •Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) < 85 at Screening.
- •NT-proBNP ≥ 300 pg/mL (NT-proBNP ≥ 225 pg/mL is permitted for African American participants) (Part C and D nHCM only).
排除标准
- •Invasive septal reduction therapy < 180 days prior to or during Screening.
- •Documented history of active or untreated obstructive coronary artery disease during Screening or treated for obstructive coronary artery disease < 180 days prior to Screening.
- •Documented history of myocardial infarction with residual wall motion abnormalities < 180 days prior to or during Screening.
- •Significant valvular heart disease (moderate or greater aortic stenosis or regurgitation, moderate or greater mitral stenosis or regurgitation not due to systolic anterior motion of the mitral valve)
- •History of LV systolic dysfunction (LVEF < 0.45) or stress cardiomyopathy at any time.
- •Known or suspected infiltrative or storage disorder causing cardiac hypertrophy that may mimic HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
- •A history of unexplained syncope <180 days prior to or during Screening.
- •A history of sustained ventricular tachyarrhythmia or sudden cardiac arrest < 180 days prior or during Screening.
- •A history of known appropriate implantable cardioverter defibrillator (ICD) discharge <180 days prior to or during Screening or ICD implanted < 14 days prior to Screening.
- •History of permanent AF or atrial flutter. Documented AF or atrial flutter requiring rhythm restoring treatment < 180 days prior to Screening Visit (participants with documented AF or atrial flutter requiring rhythm restoring treatment ≥ 180 days prior to Screening require adequate anticoagulation.)
- •Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator or Medical Monitor to pose a risk to participant safety at Screening (QTcF < 530 ms is permitted for participants with documented bundle branch blockage (BBB) and/or cardiac pacing).
- •Receiving a CMI (e.g., Camzyos® [mavacamten] or aficamten) < 90 days prior to Screening.
研究组 & 干预措施
Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy
Experimental
EDG-7500 once daily for up to 28 days.
干预措施: EDG-7500 (Drug)
Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy
Experimental
EDG-7500 daily for up to 24 months in new participants and participants who have completed Part B or C.
干预措施: EDG-7500 (Drug)
Part A: EDG-7500 Single Dose
Experimental
干预措施: EDG-7500 (Drug)
Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy
Experimental
EDG-7500 once daily for up to 28 days.
干预措施: EDG-7500 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: From screening through study completion (Part A: Up to 38 days; Part B and C: Up to 73 days; Part D: Up to 18 months)
次要结局
- Change from baseline in cardiac biomarkers(From baseline through study completion (Part B and C: Up to 38 days; Part D: Up to 18 months))
- Change from baseline in cardiac biomarkers(From baseline through study completion (Part B and C: Up to 38 days; Part D: Up to 18 months))
- Change from baseline in left ventricular outflow tract (LVOT) gradient(From baseline through study completion (Part A: Up to 10 days; Part B: Up to 38 days; Part D: Up to 18 months))
- Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax)(From baseline through study completion (Part A: Up to 10 days))
研究者
研究点 (29)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy of QBECO in Moderate to Severe Ulcerative ColitisUlcerative ColitisNCT02426372Qu Biologics Inc.11
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel DiseaseInflammatory Bowel DiseaseNCT01666327Mitsubishi Tanabe Pharma Corporation18
已完成
3 期
A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600gPsoriasisNCT00096603Genentech, Inc.450
尚未招募
不适用
LCAR-M61S and LCAR-M61D in Treatment of Relapsed/Refractory Multiple MyelomaRelapsed/Refractory Multiple MyelomaNCT06472479The First Affiliated Hospital with Nanjing Medical University66
已完成
1 期
GEN1046 Safety and PK in Subjects With Advanced Solid MalignanciesSolid TumorNCT04937153Genmab18