A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults
ConditionPulmonary Arterial Hypertension
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor35Pharma Inc
About this trial
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 criteria
Qualifiers
Male and female participants, 18 years of age and older.
Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg.
A minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn·sec·cm-5 and,
A pulmonary artery wedge pressure (PAWP) of ≤ 15 mm Hg.
Disqualifiers
PH WHO Groups 2, 3, 4 or 5.
Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
Any symptomatic coronary disease events.
History of heart transplant or on heart transplant list.
Trial design
Treatments tested in this trial
- HS235
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov