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

Phase 1

Active, not recruiting

• Conditions: Pulmonary Arterial Hypertension (PAH)
• Interventions: Biological: HS135

• Registration Number: NCT06493461
• Lead Sponsor: 35Pharma Inc

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-05
• Study First Posted: 2024-07-10
• Study Start: 2024-10-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-12
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HS135	HS135	Subcutaneous Injection

Primary Outcome Measures

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

Trial Locations

Locations (2)

Site-501; 🇨🇦 Edmonton, Alberta, Canada

Site-202; 🇩🇪 Greifswald, Germany