HS235 Treatment for Pulmonary Arterial Hypertension
A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults
Recruiting
Phase 1Phase 2Interventional Study
Pulmonary Arterial Hypertension
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
35Pharma Inc · Industry
Who this trial is looking for
This trial is looking for adults with pulmonary arterial hypertension (PAH) who are already on certain medications for their condition. Participants will receive an additional treatment and be closely monitored during the trial.
Are You a Good Fit for This Trial?
Rules you outGroups 2, 3, 4 or 5 pulmonary hypertensionSevere Chronic Obstructive Pulmonary Disease (COPD)Severe Interstitial Lung Disease (ILD)
You may be able to join if
I am 18 years of age or older
I have been diagnosed with pulmonary arterial hypertension
I have symptoms classified as WHO Functional class II to IV
I can walk at least 150 meters in 6 minutes
I am stable on at least 2 approved PAH therapies and diuretics
I have a Body Mass Index (BMI) between 18.5 and 40
I can attend study visits and follow the study's requirements
You may not be able to join if
I have been hospitalized for any worsening condition within the last 4 weeks
I have uncontrolled high blood pressure
I have had a heart transplant or am on the transplant list
I have a history of severe lung disease
I have experienced a stroke within the last 90 days
I have severe kidney failure
I have elevated liver enzymes
I have untreated or poorly controlled sleep apnea
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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)
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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…
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).
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