NCT06493461终止1 期
Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy
35Pharma Inc2 个研究点 分布在 2 个国家目标入组 5 人开始时间: 2024年10月23日最近更新:
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
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults
详细描述
Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 and female patients, 18 years of age and older.
- •Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg
- •Documented diagnostic RHC at any time prior to screening.
- •Diagnosis of WHO PAH Group
- •Symptomatic PAH classified as WHO FC II to IV.
- •Baseline RHC performed during the Screening Period documenting a minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn ・ sec ・ cm-5 and a pulmonary artery wedge pressure (PAWP) of ≤ 15 mmHg.
- •On stable doses of at least 2 background PAH therapies.
排除标准
- •Left ventricular ejection fraction < 50% at screening.
- •Any symptomatic coronary disease events within 6 months of the screening visit.
- •Uncontrolled systemic hypertension.
- •History of restrictive, constrictive or congestive cardiomyopathy.
- •History of atrial septostomy.
- •Patients who have an abnormality in the Echocardiogram or in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study.
- •Pulmonary function test (PFT) values of forced vital capacity (FVC) and or FEV1 < 60% predicted at the screening visit or within 6 months prior to the screening visit.
研究组 & 干预措施
HS135
Experimental
Subcutaneous Injection
干预措施: HS135 (Biological)
结局指标
主要结局
Adverse Events (AEs)
时间窗: Up to 24 weeks
Change from Baseline in Physical Examination
时间窗: Up to 24 weeks
Physical Examination will include the assessment of body systems.
Change from Baseline in Clinical Laboratory Parameters
时间窗: Up to 24 weeks
Change from Baseline in Blood Pressure
时间窗: Up to 24 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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