Group 2 Pulmonary Hypertension, HFpEF - Heart Failure With Preserved Ejection Fraction, HFrEF - Heart Failure With Reduced Ejection Fraction
Conditions
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
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.
Interventions
DRUGJK07
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.
Sponsors
Salubris Biotherapeutics Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of TEAEs [Safety and tolerability] | Study entry through week 26 | Incidence and severity of treatment emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic - Cmax | Study entry through week 26 | Characterize the JK07 PK profile through Peak Plasma Concentration (Cmax) following IV administration |
| Pharmacokinetics - Tmax | Study entry through week 26 | Characterize the JK07 PK profile through Time to Peak Plasma Concentration (Tmax) following IV administration |
| Pharmacokinetics - AUC0-last | Study entry through week 26 | Characterize the JK07 PK profile through area under the concentration-time curve from time 0 to last quantifiable concentration (AUC0-last) following IV administration |
| Pharmacokinetics - AUC0-inf | Study entry through week 26 | Characterize the JK07 PK profile through area under the concentration-time curve from time 0 to infinity (AUC0-inf) following IV administration |
| Pharmacokinetics - t1/2 | Study entry through week 26 | Characterize the JK07 PK profile through half-life (t1/2) following IV administration |
| Pharmacokinetics - λz | Study entry through week 26 | Characterize the JK07 PK profile through elimination rate constant (λz) following IV administration |
| Pharmacokinetics - CL | Study entry through week 26 | Characterize the JK07 PK profile through systemic clearance (CL) following IV administration |
| Pharmacokinetics - Vz | Study entry through week 26 | Characterize the JK07 PK profile through volume of distribution (Vz) following IV administration |
Countries
United States
Outcome results
None listed