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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called JK07 in people with heart failure who also have pulmonary hypertension — specifically a type where both the veins going into the lungs AND the lung arteries themselves are under excess pressure (combined pre- and post-capillary pulmonary hypertension). **You may be eligible if...** - You have heart failure with Class II or III symptoms (some or moderate limitations on activity) - You have either heart failure with reduced ejection fraction (HFrEF, pumping function ≤40%) or preserved ejection fraction (HFpEF, 40-70%) - A right heart catheterization has confirmed elevated pressures in both the lung veins and lung arteries **You may NOT be eligible if...** - Your pulmonary hypertension belongs to a different WHO category (Group 1, 3, 4, or 5 — meaning it's not caused by left heart disease) - You have a known lung condition or have had part of your lung removed - Your BMI is above 45 - You have a contraindication to having a right heart catheter left in place for about 6 hours Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(1)

Saint Francis Heart and Vascular Institute

Tulsa, Oklahoma, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07221513


Related Trials