Phase 1b Double-Blind, Placebo-Controlled, MAD Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Incidence and Number of Adverse Events (AEs)
研究概览
简要总结
A Study of HS135 for the Treatment of in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
详细描述
Phase 1b, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double-blind, Placebo controlled
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
- •Patients are eligible to be included in the study only if they meet at least all the following criteria:
- •Male or female, >18 years of age.
- •CardioMEMS™ Heart Failure System implanted during standard of care at least 90 days before Screening.
- •Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) at least 45% as measured by echocardiography during Screening.
- •New York Heart Association (NYHA) class II, III or IV heart failure symptoms.
- •BMI ≥ 30 kg/m
- •Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •Decompensated heart failure.
- •Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to Screening.
- •Implantation of cardiac resynchronization therapy (CRT) device within 90 days prior to Screening.
- •Planned cardiovascular revascularization or major cardiac surgery or planned implantation of CRT device.
- •History of heart transplant or on heart transplant list.
- •Uncontrolled systemic hypertension.
- •Patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study.
- •Patients who have full pneumonectomy or a severe chronic pulmonary disorder that in the opinion of the investigator increases the risk of participating in the study.
研究组 & 干预措施
Investigational Product
HS135 Subcutaneous Injection
干预措施: HS135 (Biological)
Placebo
Subcutaneous Injection
干预措施: Placebo (Other)
结局指标
主要结局
Incidence and Number of Adverse Events (AEs)
时间窗: Up to 24 weeks
An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of patients who experience an AE will be reported.
Change from Baseline in Clinical Laboratory Parameters (Hematology): White Blood Cell Count
时间窗: Up to 24 weeks
Blood samples will be collected to determine the White Blood Cell Count at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): Platelet Count
时间窗: Up to 24 weeks
Blood samples will be collected to determine the Platelet Count at designated time points up to 24 weeks.
Change from Baseline in Clinical Laboratory Parameters (Hematology): Red Blood Cell Count
时间窗: Up to 24 weeks
Blood samples will be collected to determine the Red Blood Cell Count at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): Hemoglobin
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Hemoglobin at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): Hematocrit
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Hematocrit at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Albumin
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Albumin at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Aspartate aminotransferase (AST)
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of AST designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alanine aminotransferase (ALT)
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of ALT designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alkaline phosphatase (ALP)
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of ALP designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Total Bilirubin
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Total Bilirubin at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Urea
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Urea at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Calcium
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Calcium at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Creatinine
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Creatinine at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Potassium
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Potassium at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Sodium
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Sodium at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Glucose
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Glucose at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Total Cholesterol
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Total Cholesterol at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): High-density Lipoprotein-cholesterol (HDL-c)
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of HDL-c at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Low-density Lipoprotein-cholesterol (LDL-c)
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of LDL-c at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Chloride
时间窗: Up to 24 weeks
Blood samples will be collected to determine concentration of Chloride at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Protein
时间窗: Up to 24 weeks
Urine samples will be collected to determine the presence of Protein at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Blood (occult)
时间窗: Up to 24 weeks
Urine samples will be collected to determine the presence of Blood (occult) at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Ketones
时间窗: Up to 24 weeks
Urine samples will be collected to determine the presence of Ketones at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Leukocyte Esterase
时间窗: Up to 24 weeks
Urine samples will be collected to determine the presence Leukocyte Esterase of at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Nitrites
时间窗: Up to 24 weeks
Urine samples will be collected to determine the presence of Nitrites at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Bilirubin
时间窗: Up to 24 weeks
Urine samples will be collected to determine the presence of Bilirubin at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Glucose
时间窗: Up to 24 weeks
Urine samples will be collected to determine the presence of Glucose at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Urobilinogen
时间窗: Up to 24 weeks
Urine samples will be collected to determine concentration of Urobilinogen at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): pH
时间窗: Up to 24 weeks
Urine samples will be collected to determine the pH at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Specific Gravity
时间窗: Up to 24 weeks
Urine samples will be collected to determine the Specific Gravity at designated time points up to 24 weeks
次要结局
- Change from Baseline in mean pulmonary artery diastolic pressure (mPADP) at designated time points up to 24 weeks(Up to 24 weeks)
- Change from Baseline in mean pulmonary artery pressure (mPAP) at designated time points up to 24 weeks(Up to 24 weeks)
- Change from Baseline in mean pulmonary artery systolic pressure (mPASP) at designated time points up to 24 weeks(Up to 24 weeks)
- Change in New York Heart Association (NYHA) Class at designated time points up to 24 weeks(Up to 24 weeks)
- Change from Baseline in number of hospitalizations or urgent outpatient visits for heart failure during the treatment period at designated time points at designated time points up to 24 weeks(Up to 24 weeks)
- Change from Baseline to Week 24 in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at designated time points up to 24 weeks(Up to 24 weeks)
- Change from Baseline in 6-minute walk distance (6MWD) at designated time points up to 24 weeks(Up to 24 weeks)
- Change from Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CS) and Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OS) at designated time points up to 24 weeks(Up to 24 weeks)