Trials / Recruiting
RecruitingNCT07221513
Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Salubris Biotherapeutics Inc · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
- HFrEF - Heart Failure With Reduced Ejection Fraction
- HFpEF - Heart Failure With Preserved Ejection Fraction
- Group 2 Pulmonary Hypertension
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-12-15
- Primary completion
- 2026-09-01
- Completion
- 2027-10-01
- First posted
- 2025-10-28
- Last updated
- 2026-01-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07221513. Inclusion in this directory is not an endorsement.