A Phase 2 interventional study of JK07 in HFrEF - Heart Failure With Reduced Ejection Fraction, HFpEF - Heart Failure With Preserved Ejection Fraction and Group 2 Pulmonary Hypertension, sponsored by Salubris Biotherapeutics Inc. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Salubris Biotherapeutics Inc · Phase 2, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
Browse Heart Failure studies →Salubris Biotherapeutics Inc is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Key Inclusion Criteria:
Key Exclusion Criteria:
JK07 administered by intravenous (IV) infusion
Drug: JK07
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.
Incidence and severity of TEAEs [Safety and tolerability]
Incidence and severity of treatment emergent adverse events
Time frame: Study entry through week 26
Pharmacokinetic - Cmax
Characterize the JK07 PK profile through Peak Plasma Concentration (Cmax) following IV administration
Time frame: Study entry through week 26
Pharmacokinetics - Tmax
Characterize the JK07 PK profile through Time to Peak Plasma Concentration (Tmax) following IV administration
Time frame: 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
Time frame: 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
Time frame: Study entry through week 26
Pharmacokinetics - t1/2
Characterize the JK07 PK profile through half-life (t1/2) following IV administration
Time frame: Study entry through week 26
Pharmacokinetics - λz
Characterize the JK07 PK profile through elimination rate constant (λz) following IV administration
Time frame: Study entry through week 26
Pharmacokinetics - CL
Characterize the JK07 PK profile through systemic clearance (CL) following IV administration
Time frame: Study entry through week 26
Pharmacokinetics - Vz
Characterize the JK07 PK profile through volume of distribution (Vz) following IV administration
Time frame: Study entry through week 26
Plan to share: No
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This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Salubris Biotherapeutics Inc