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Clinical Trials in the USA / NCT07143448
Recruiting Phase 1/2

A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults

NCT07143448 · tracked via the Priya Life Science USA tracker
Sponsor
35Pharma Inc
Phase
Phase 1/2
Started
2026-08-19
Last updated
2026-09-11

Condition(s) studied

Pulmonary Arterial Hypertension

Investigational drug(s) / intervention(s)

HS235Placebo

HS235: Subcutaneous Injection

Placebo: Subcutaneous Injection

Study summary

Phase 1b/2 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 Hypertension (PAH)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Participants are eligible to be included in the study only if they meet all of the following criteria: 1. Male and female participants, 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. Baseline RHC performed during the Screening Period documenting: 1. A minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn·sec·cm-5 and, 2. A pulmonary artery wedge pressure (PAWP) of ≤ 15 mm Hg. 4. Diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1. 5. Symptomatic PAH classified as WHO Functional class II to IV. 6. On stable doses of at least 2 approved background PAH therapies and diuretics. 7. 6-Minute Walk Distance (6MWD) ≥ 150 m and ≤ 500 m repeated twice during screening. 8. Ability to adhere to study visit schedule and understand and comply with all protocol requirements. Exclusion Criteria: 1. PH WHO Groups 2, 3, 4 or 5. 2. Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening. 3. Any symptomatic coronary disease events. 4. History of heart transplant or on heart transplant list. 5. Uncontrolled systemic hypertension. 6. History of restrictive, constrictive or congestive cardiomyopathy. 7. History of significant mitral regurgitation or aortic regurgitation valvular disease. 8. Untreated or poorly controlled moderate or severe obstructive sleep apnea. 9. A diagnosis of worse than moderate COPD or worse than mild ILD. 10. Cerebrovascular event within 90 days prior to screening 11. A pneumonectomy or lobectomy 12. Having received an activin signaling inhibitor such as sotatercept at any time prior to screening 13. A Hgb \> sex-specific ULN 14. Platelets count \< 100,000/mm3 15. Severe (stage ≥4) renal failure with eGFR \< 30 mL/min/m2 16. Abnormally elevated liver function enzymes (ALT or AST \> 3X ULN, or total bilirubin \> 1.5X ULN).

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Investigational Site-102 Tampa Florida Recruiting
Investigational Site-104 Providence Rhode Island Recruiting
Investigational Site-305 Barcelona Spain Recruiting
Investigational Site-903 London London Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07143448 on ClinicalTrials.gov ↗ ← All trials in the USA