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

May 26, 2025 updated by: 35Pharma Inc

Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • Site-501
  • Germany
      • Greifswald, Germany, 17475
        • Site-202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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. Documented diagnostic RHC at any time prior to screening.
  4. Diagnosis of WHO PAH Group 1.
  5. Symptomatic PAH classified as WHO FC II to IV.
  6. 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.
  7. On stable doses of at least 2 background PAH therapies.

Exclusion Criteria:

  1. Left ventricular ejection fraction < 50% at screening.
  2. Any symptomatic coronary disease events within 6 months of the screening visit.
  3. Uncontrolled systemic hypertension.
  4. History of restrictive, constrictive or congestive cardiomyopathy.
  5. History of atrial septostomy.
  6. 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.
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HS135
Subcutaneous Injection
Biological: HS135
HS135 is dosed subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: Up to 24 weeks
Up to 24 weeks
Change from Baseline in Physical Examination
Time Frame: Up to 24 weeks
Physical Examination will include the assessment of body systems.
Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters
Time Frame: Up to 24 weeks
Up to 24 weeks
Change from Baseline in Blood Pressure
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

35Pharma Inc

Investigators

  • Study Director: Monique Champagne, M.Sc., VP, Clinical Operations

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2024

Primary Completion (Actual)

March 31, 2025

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS135-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Arterial Hypertension (PAH)

Clinical Trials on HS135

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe