Actively Recruiting

Phase 2
Age: 18Years - 85Years
All Genders
NCT07221513

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

Led by Salubris Biotherapeutics Inc · Updated on 2026-01-20

30

Participants Needed

1

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with heart failure classified as New York Heart Association Class II-III
  • Participants classified as having HFrEF (LVEF 64 40%) or HFpEF (LVEF >40% and 6470%)
  • Evidence of combined post- and pre-capillary pulmonary hypertension (cpcPH) confirmed by right heart catheterization with:
    • Pulmonary vascular resistance (PVR) 652.5 Wood units
    • Mean pulmonary arterial pressure (mPAP) 6525 mmHg
    • Pulmonary artery wedge pressure (PAWP) 6516 mmHg
Not Eligible

You will not qualify if you...

  • Diagnosis of pulmonary hypertension in WHO Group 1, Group 3, Group 4, or Group 5
  • Contraindication to right heart catheterization that can remain in place for approximately 6 hours
  • Pre-existing lung diseases including congenital abnormalities, full or partial pneumonectomy, or prior therapeutic radiation of lungs or mediastinum
  • Body mass index (BMI) greater than 45 kg/m at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Saint Francis Heart and Vascular Institute

Tulsa, Oklahoma, United States, 74136

Actively Recruiting

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Research Team

A

Amanda McEwen

CONTACT

A

Ashleigh Chasteen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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