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

35Pharma Inc

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Pulmonary Arterial Hypertension

Treatments: Biological: HS235; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07143448

HS235-002

Details and patient eligibility

About

Phase 1b/2 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)

Full description

A Phase 1b/2, 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)

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

1. Male and female participants, 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. Baseline RHC performed during the Screening Period documenting:

   1. A minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn·sec·cm-5 and,
   2. A pulmonary artery wedge pressure (PAWP) of ≤ 15 mm Hg.

4. Diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1.

5. Symptomatic PAH classified as WHO Functional class II to IV.

6. On stable doses of at least 2 approved background PAH therapies and diuretics.

7. 6-Minute Walk Distance (6MWD) ≥ 150 m and ≤ 500 m repeated twice during screening.

8. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.

Exclusion criteria

1. PH WHO Groups 2, 3, 4 or 5.
2. Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
3. Any symptomatic coronary disease events.
4. History of heart transplant or on heart transplant list.
5. Uncontrolled systemic hypertension.
6. History of restrictive, constrictive or congestive cardiomyopathy.
7. History of significant mitral regurgitation or aortic regurgitation valvular disease.
8. Untreated or poorly controlled moderate or severe obstructive sleep apnea.
9. A diagnosis of worse than moderate COPD or worse than mild ILD.
10. Cerebrovascular event within 90 days prior to screening
11. A pneumonectomy or lobectomy
12. Having received an activin signaling inhibitor such as sotatercept at any time prior to screening
13. A Hgb > sex-specific ULN
14. Platelets count < 100,000/mm3
15. Severe (stage ≥4) renal failure with eGFR < 30 mL/min/m2
16. Abnormally elevated liver function enzymes (ALT or AST > 3X ULN, or total bilirubin > 1.5X ULN).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

HS235

Experimental group

Description:

HS235 Subcutaneous Injection

Treatment:

Biological: HS235

Placebo

Placebo Comparator group

Description:

Subcutaneous Injection

Treatment:

Other: Placebo