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

NCT07143448 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HS235-002
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Incidence and Number of Adverse Events (AEs)

  An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of patients who experience an AE will be reported.

  up to 24 weeks

Study Arms (2)

HS235

EXPERIMENTAL

HS235 Subcutaneous Injection

Biological: HS235

Placebo

PLACEBO COMPARATOR

Subcutaneous Injection

Other: Placebo

Interventions

HS235 BIOLOGICAL

Subcutaneous Injection

HS235

Placebo OTHER

Subcutaneous Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 35Pharma Inc: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Monique Champagne, M.Sc

  35Pharma Inc

  STUDY DIRECTOR

Central Study Contacts

Danaë Lemieux-Uresandi, M.Sc

CONTACT

+1.438.439.7763; clinicaltrials@35pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-08