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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-01-31

Brief Summary

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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 Hypertension (PAH)

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Detailed Description

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A Phase Ib, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of the Activin Signaling Inhibitor HS235 Added to Background Treatment in Adults with Pulmonary Arterial Hypertension (PAH)

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HS235

HS235 Subcutaneous Injection

Group Type EXPERIMENTAL

HS235

Intervention Type BIOLOGICAL

Subcutaneous Injection

Placebo

Subcutaneous Injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subcutaneous Injection

Interventions

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HS235

Subcutaneous Injection

Intervention Type BIOLOGICAL

Placebo

Subcutaneous Injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:

1. Male and female patients, 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 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.
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 for at least 90 days prior to Screening.
7. 6-Minute Walk Distance (6MWD) ≥ 150m and ≤ 500m repeated twice during screening.
8. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.

Exclusion Criteria

1. Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
2. Any symptomatic coronary disease events within 6 months of the screening visit.
3. History of heart transplant or on heart transplant list.
4. Uncontrolled systemic hypertension.
5. History of restrictive, constrictive or congestive cardiomyopathy.
6. History of significant valvular stenosis or regurgitation.
7. Untreated or poorly controlled moderate or severe obstructive sleep apnea.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No