A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults

NCT06493461 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: HS135-002
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 2

Brief Summary

A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults

Conditions

Pulmonary Arterial Hypertension (PAH)

Outcome Measures

Primary Outcomes (4)

• Adverse Events (AEs)

  Up to 24 weeks

• Change from Baseline in Physical Examination

  Physical Examination will include the assessment of body systems.

  Up to 24 weeks

• Change from Baseline in Clinical Laboratory Parameters

  Up to 24 weeks

• Change from Baseline in Blood Pressure

  Up to 24 weeks

Study Arms (1)

HS135

EXPERIMENTAL

Subcutaneous Injection

Biological: HS135

Interventions

HS135 BIOLOGICAL

HS135 is dosed subcutaneously

HS135

Eligibility Criteria

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

You may qualify if:

• 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
• Documented diagnostic RHC at any time prior to screening.
• Diagnosis of WHO PAH Group 1.
• Symptomatic PAH classified as WHO FC II to IV.
• Baseline RHC performed during the Screening Period documenting a minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn・sec・cm-5 and a pulmonary artery wedge pressure (PAWP) of ≤ 15 mmHg.
• On stable doses of at least 2 background PAH therapies.

You may not qualify if:

• Left ventricular ejection fraction \< 50% at screening.
• Any symptomatic coronary disease events within 6 months of the screening visit.
• Uncontrolled systemic hypertension.
• History of restrictive, constrictive or congestive cardiomyopathy.
• History of atrial septostomy.
• Patients who have an abnormality in the Echocardiogram or in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study.
• Pulmonary function test (PFT) values of forced vital capacity (FVC) and or FEV1 \< 60% predicted at the screening visit or within 6 months prior to the screening visit.

Sponsors & Collaborators

• 35Pharma Inc: lead

Study Sites (2)

Site-501

Edmonton, Alberta, T6G 2C8, Canada

Location

Site-202

Greifswald, 17475, Germany

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Monique Champagne, M.Sc.

  VP, Clinical Operations

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 10, 2024
• Study Start: October 23, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

CA (1); DE (1)