Status:
TERMINATED
A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults
Lead Sponsor:
35Pharma Inc
Conditions:
Pulmonary Arterial Hypertension (PAH)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 (PA...
Eligibility Criteria
Inclusion
- 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 1.
- 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
- 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.
Key Trial Info
Start Date :
October 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06493461
Start Date
October 23 2024
End Date
March 31 2025
Last Update
May 30 2025
Active Locations (2)
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1
Site-501
Edmonton, Alberta, Canada, T6G 2C8
2
Site-202
Greifswald, Germany, 17475