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

NCT07221513 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: JK07.2.04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 approximately 30 participants will be enrolled and receive JK07 high dose in this open-label trial.

Conditions

Group 2 Pulmonary Hypertension; HFrEF - Heart Failure With Reduced Ejection Fraction; HFpEF - Heart Failure With Preserved Ejection Fraction

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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of TEAEs [Safety and tolerability]

  Incidence and severity of treatment emergent adverse events

  Study entry through week 26

Secondary Outcomes (8)

• Pharmacokinetic - Cmax

  Study entry through week 26

• Pharmacokinetics - Tmax

  Study entry through week 26

• Pharmacokinetics - AUC0-last

  Study entry through week 26

• Pharmacokinetics - AUC0-inf

  Study entry through week 26

• Pharmacokinetics - t1/2

  Study entry through week 26

Study Arms (1)

JK07 high dose

EXPERIMENTAL

JK07 administered by intravenous (IV) infusion

Drug: JK07

Interventions

JK07 DRUG

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.

JK07 high dose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salubris Biotherapeutics Inc: lead

Study Sites (1)

Saint Francis Heart and Vascular Institute

Tulsa, Oklahoma, 74136, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary; Heart Failure, Systolic; Heart Failure, Diastolic; Fibromatosis, Gingival, 2

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Central Study Contacts

Amanda McEwen

CONTACT

888-521-8961; Info@SalubrisBio.com

Ashleigh Chasteen

CONTACT

888-521-8961; Info@SalubrisBio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: October 28, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)