Status:
NOT_YET_RECRUITING
A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults
Lead Sponsor:
35Pharma Inc
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase 1b Study of HS235 Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of the Activin Signaling Inhibitor HS235 Added to Background Treatment in Adults with Pulmonary Arterial ...
Detailed Description
A Phase Ib, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of the Activin Signaling Inhibitor HS23...
Eligibility Criteria
Inclusion
- Patients are eligible to be included in the study only if they meet all of the following 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.
- Baseline Right Heart Catheterization (RHC) performed during the Screening Period documenting minimum pulmonary vascular resistance (PVR) of ≥ 5 Wood units (WU) or ≥ 400 dyn·sec·cm-5 and a pulmonary artery wedge pressure (PAWP) of ≤ 15 mm Hg.
- Diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1.
- Symptomatic PAH classified as WHO Functional class II to IV.
- On stable doses of at least 2 approved background PAH therapies and diuretics for at least 90 days prior to Screening.
- 6-Minute Walk Distance (6MWD) ≥ 150m and ≤ 500m repeated twice during screening.
- Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
Exclusion
- Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
- Any symptomatic coronary disease events within 6 months of the screening visit.
- History of heart transplant or on heart transplant list.
- Uncontrolled systemic hypertension.
- History of restrictive, constrictive or congestive cardiomyopathy.
- History of significant valvular stenosis or regurgitation.
- Untreated or poorly controlled moderate or severe obstructive sleep apnea.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07143448
Start Date
October 1 2025
End Date
January 1 2028
Last Update
August 27 2025
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