Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension

Phase 2RecruitingNCT07221513

Salubris Biotherapeutics Inc30 enrolled

Overview

This is a Phase 2a, open-label, multiple-dose study to assess the safety, tolerability, and efficacy of JK07 in participants 18 to 85 years of age with diagnosed HF and cpcPH. At least 20 and up to approximately 30 participants will be enrolled and receive JK07 high dose in this open-label trial.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HFrEF - Heart Failure With Reduced Ejection Fraction HFpEF - Heart Failure With Preserved Ejection Fraction Group 2 Pulmonary Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Participants with HF New York Heart Association Class II-III. * Participants will be classified as having HFrEF (LVEF ≤ 40%) or HFpEF (LVEF \>40% and ≤70%). * Right heart catheterization (RHC) based evidence of cpcPH: * PVR ≥2.5 WU; AND * mPAP ≥25 mmHg; AND * PAWP ≥16 mmHg Key Exclusion Criteria: * Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5. * Contraindicated to RHC that can be left in place for approximately 6 hours. * A diagnosis of pre-existing lung disease including congenital abnormalities, full or partial pneumonectomy, or previous therapeutic radiation of lungs or mediastinum. * Body mass index (BMI) \>45 kg/m² at screening.