RecruitingPhase 2NCT07221513

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

A Phase 2a, Open-Label Study to Assess the Safety, Tolerability, and Efficacy of JK07 in Participants With Heart Failure and Group 2 Combined Post-Capillary and Pre-Capillary Pulmonary Hypertension (RENEU-PH)

Sponsor

Salubris Biotherapeutics Inc

Enrollment

30 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

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

Exclusion Criteria4

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.

Interventions

DRUGJK07

JK07 is a fully human anti-human epidermal growth factor receptor 3 (also known as ErbB3 or HER3) antibody fused with the epidermal growth factor (EGF)-domain of Neuregulin (NRG)-1b protein.