Pulmonary Arterial Hypertension (PAH)
Conditions
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
Interventions
BIOLOGICALHS135
HS135 is dosed subcutaneously
Sponsors
35Pharma Inc
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients, 18 years of age and older. 2. Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg 3. Documented diagnostic RHC at any time prior to screening. 4. Diagnosis of WHO PAH Group 1. 5. Symptomatic PAH classified as WHO FC II to IV. 6. 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. 7. On stable doses of at least 2 background PAH therapies.
Exclusion criteria
1. Left ventricular ejection fraction \< 50% at screening. 2. Any symptomatic coronary disease events within 6 months of the screening visit. 3. Uncontrolled systemic hypertension. 4. History of restrictive, constrictive or congestive cardiomyopathy. 5. History of atrial septostomy. 6. 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. 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Up to 24 weeks | — |
| Change from Baseline in Physical Examination | Up to 24 weeks | Physical Examination will include the assessment of body systems. |
| Change from Baseline in Clinical Laboratory Parameters | Up to 24 weeks | — |
| Change from Baseline in Blood Pressure | Up to 24 weeks | — |
Countries
Canada, Germany
Outcome results
None listed