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

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.

Study Overview

• Status: Withdrawn
• Conditions: HFpEF - Heart Failure With Preserved Ejection Fraction; HFrEF - Heart Failure With Reduced Ejection Fraction; Group 2 Pulmonary Hypertension
• Intervention / Treatment: Drug: JK07

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Saint Francis Heart and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JK07 high dose; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of TEAEs [Safety and tolerability]	Incidence and severity of treatment emergent adverse events	Study entry through week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic - Cmax	Characterize the JK07 PK profile through Peak Plasma Concentration (Cmax) following IV administration	Study entry through week 26
Pharmacokinetics - Tmax	Characterize the JK07 PK profile through Time to Peak Plasma Concentration (Tmax) following IV administration	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	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	Study entry through week 26
Pharmacokinetics - t1/2	Characterize the JK07 PK profile through half-life (t1/2) following IV administration	Study entry through week 26
Pharmacokinetics - λz	Characterize the JK07 PK profile through elimination rate constant (λz) following IV administration	Study entry through week 26
Pharmacokinetics - CL	Characterize the JK07 PK profile through systemic clearance (CL) following IV administration	Study entry through week 26
Pharmacokinetics - Vz	Characterize the JK07 PK profile through volume of distribution (Vz) following IV administration	Study entry through week 26

Collaborators and Investigators

• Sponsor: Salubris Biotherapeutics Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Actual): April 16, 2026
• Study Completion (Actual): April 16, 2026

Study Registration Dates

• First Submitted: August 20, 2025
• First Submitted That Met QC Criteria: October 23, 2025
• First Posted (Actual): October 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Pulmonary Hypertension; Diastolic Heart Failure; Systolic Heart Failure; Heart Failure with Preserved Ejection Fraction; HER3; Heart Failure with Reduced Ejection Fraction; HFrEF; HFpEF; Neuregulin 1; NRG-1; HER4; ErbB4; Heart Failure NYHA Class III; Heart Failure NYHA Class II; Group 2 Pulmonary Hypertension; cpcPH
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Heart Failure; Hypertension, Pulmonary; Heart Failure, Diastolic; Heart Failure, Systolic; Fibromatosis, Gingival, 2
• Other Study ID Numbers: JK07.2.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No