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临床试验/NCT06493461
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

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

发起方
35Pharma Inc
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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