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
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Adverse Events (AEs)
Study Overview
Brief Summary
A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
HS135
Subcutaneous Injection
Intervention: HS135 (Biological)
Outcomes
Primary Outcomes
Adverse Events (AEs)
Time Frame: Up to 24 weeks
Change from Baseline in Physical Examination
Time Frame: Up to 24 weeks
Physical Examination will include the assessment of body systems.
Change from Baseline in Clinical Laboratory Parameters
Time Frame: Up to 24 weeks
Change from Baseline in Blood Pressure
Time Frame: Up to 24 weeks
Secondary Outcomes
No secondary outcomes reported
