Trials / Recruiting
RecruitingNCT06369298
Study of JK07 in Patients With Chronic Heart Failure
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 282 (estimated)
- Sponsor
- Salubris Biotherapeutics Inc · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure. There will be 2 cohorts in this study: Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%. Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.
Conditions
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. |
| DRUG | Placebo | 0.9% sodium chloride |
Timeline
- Start date
- 2024-03-28
- Primary completion
- 2025-12-31
- Completion
- 2026-06-30
- First posted
- 2024-04-16
- Last updated
- 2025-08-22
Locations
62 sites across 4 countries: United States, Canada, China, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06369298. Inclusion in this directory is not an endorsement.