RecruitingPhase 1 / Phase 2

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

Phase 1b/2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HS235 Added to Background Treatment in Adults With PAH

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age: 18 Years and older
Sex: All sexes
Healthy volunteers: Not accepted
Compensation: Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation: Not stated

Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
Participants are monitored closely by the research team throughout the study.
Some participants may receive access to an investigational treatment, which is still being studied.
Your participation helps researchers learn whether this approach could help future patients.

About this study

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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).