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Not yet recruiting NCT07143448

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

Phase I Interventional Pulmonary Arterial Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HS235, Placebo.
Who it may be relevant to
Registry conditions: Pulmonary Arterial Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase Ib, 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

Overview

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)

Detailed description

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)

Interventions

  • Biological HS235
    Subcutaneous Injection
  • Other Placebo
    Subcutaneous Injection

Primary outcome measures

  • Incidence and Number of Adverse Events (AEs) [Time frame: up to 24 weeks]

Eligibility criteria

Inclusion criteria

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

  • Male and female patients, 18 years of age and older.
  • Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg.
  • 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.
  • Diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1.
  • Symptomatic PAH classified as WHO Functional class II to IV.
  • On stable doses of at least 2 approved background PAH therapies and diuretics for at least 90 days prior to Screening.
  • 6-Minute Walk Distance (6MWD) ≥ 150m and ≤ 500m repeated twice during screening.
  • Ability to adhere to study visit schedule and understand and comply with all protocol requirements.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07143448 · HS235-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗