HFrEF - Heart Failure With Reduced Ejection FractionPhase 2RENEU-PHNCT07221513
Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension
A Phase 2 study testing JK07 in people with HFrEF - Heart Failure With Reduced Ejection Fraction and HFpEF - Heart Failure With Preserved Ejection Fraction, run by Salubris Biotherapeutics Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- HFrEF - Heart Failure With Reduced Ejection Fraction, HFpEF - Heart Failure With Preserved Ejection Fraction, Group 2 Pulmonary Hypertension
- What is being tested?
- JK07
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 16 Apr 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Heart and Vascular Institute
Tulsa, Oklahoma, 74136
About this study
Official title: 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)
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
- HFrEF - Heart Failure With Reduced Ejection Fraction, HFpEF - Heart Failure With Preserved Ejection Fraction, Group 2 Pulmonary Hypertension
- Being tested
- JK07
- Keywords
- Heart Failure, Heart Failure with Reduced Ejection Fraction, HFrEF, HFpEF, Heart Failure with Preserved Ejection Fraction, Group 2 Pulmonary Hypertension, Pulmonary Hypertension, cpcPH, Heart Failure NYHA Class III, Heart Failure NYHA Class II, Systolic Heart Failure, Diastolic Heart Failure, Neuregulin 1, NRG-1, ErbB4, HER3, HER4
- Medical subject headings
- Heart Failure, Hypertension, Pulmonary, Heart Failure, Systolic, Heart Failure, Diastolic, Fibromatosis, Gingival, 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JK07Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| JK07 high dose | Experimental | JK07 administered by intravenous (IV) infusion Receives: Drug: JK07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of TEAEs [Safety and tolerability]
Incidence and severity of treatment emergent adverse events
Measured: Study entry through week 26
Secondary outcomes (8)
Pharmacokinetic - Cmax
Characterize the JK07 PK profile through Peak Plasma Concentration (Cmax) following IV administration
Measured: Study entry through week 26
Pharmacokinetics - Tmax
Characterize the JK07 PK profile through Time to Peak Plasma Concentration (Tmax) following IV administration
Measured: Study entry through week 26
Pharmacokinetics - AUC0-last
Characterize the JK07 PK profile through area under the concentration-time curve from time 0 to last quantifiable concentration (AUC0-last) following IV administration
Measured: Study entry through week 26
Pharmacokinetics - AUC0-inf
Characterize the JK07 PK profile through area under the concentration-time curve from time 0 to infinity (AUC0-inf) following IV administration
Measured: Study entry through week 26
Pharmacokinetics - t1/2
Characterize the JK07 PK profile through half-life (t1/2) following IV administration
Measured: Study entry through week 26
Pharmacokinetics - λz
Characterize the JK07 PK profile through elimination rate constant (λz) following IV administration
Measured: Study entry through week 26
Pharmacokinetics - CL
Characterize the JK07 PK profile through systemic clearance (CL) following IV administration
Measured: Study entry through week 26
Pharmacokinetics - Vz
Characterize the JK07 PK profile through volume of distribution (Vz) following IV administration
Measured: Study entry through week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start15 Dec 2025
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFrEF - Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salubris Biotherapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221513
- Sponsor's protocol ID
- JK07.2.04
- Acronym
- RENEU-PH
- Status last verified
- May 2026
- First submitted
- 20 Aug 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No