Status:
NOT_YET_RECRUITING
Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension
Lead Sponsor:
Salubris Biotherapeutics Inc
Conditions:
HFrEF - Heart Failure With Reduced Ejection Fraction
HFpEF - Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 a...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07221513
Start Date
November 1 2025
End Date
October 1 2027
Last Update
October 28 2025
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