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

Salubris Biotherapeutics

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: JK07

Study type: Interventional

Funder types: Industry

Identifiers

NCT07221513

JK07.2.04

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

JK07 high dose

Experimental group

Description:

JK07 administered by intravenous (IV) infusion

Treatment:

Drug: JK07