30 Participants Needed

JK07 for Heart Failure and Pulmonary Hypertension

(RENEU-PH Trial)

AM
AC
Overseen ByAshleigh Chasteen
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Salubris Biotherapeutics Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called JK07 for individuals with heart failure and pulmonary hypertension (high blood pressure in the lungs). Researchers aim to determine if JK07 is safe and effective when administered in high doses through an IV. Candidates with heart failure exhibiting moderate symptoms and a diagnosis of pulmonary hypertension may be suitable for participation. Participants will receive JK07 and undergo close monitoring to assess their response to the treatment. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that JK07 is likely to be safe for humans?

Research has shown that JK07 has undergone testing in earlier studies for safety in people with heart failure. In these studies, patients received several doses of JK07, and the treatment was generally well-tolerated. No major safety issues were reported, suggesting that JK07 might be safe for humans. However, like any treatment, side effects may occur and can vary from person to person. Discussing potential risks with healthcare professionals before joining a trial is important.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for heart failure and pulmonary hypertension, which often include medications like ACE inhibitors, beta-blockers, or diuretics, JK07 is administered via intravenous infusion, potentially allowing for more direct and immediate effects on the cardiovascular system. Researchers are excited about JK07 because it targets specific pathways associated with heart failure and pulmonary hypertension differently than existing treatments, which could lead to improved efficacy and fewer side effects. This novel approach may help address unmet needs in patients who do not respond well to current therapies.

What evidence suggests that JK07 might be an effective treatment for heart failure and pulmonary hypertension?

Research shows that JK07 might help treat heart failure and high blood pressure in the lungs. In animal studies, JK07 improved heart function similarly to an existing treatment called NRG-1, enhancing the heart's pumping ability, which is crucial for those with heart failure. Early human trials have also shown promising results, with improvements in heart pumping efficiency, measured by left ventricular ejection fraction. These early findings suggest that JK07 could be a useful treatment for these conditions.12456

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with heart failure and a specific type of pulmonary hypertension (cpcPH). They must have certain measurements indicating the severity of their condition, like mPAP ≥25 mmHg and PAWP ≥16 mmHg. Participants should be in NYHA Class II-III heart failure, with either reduced or preserved ejection fraction.

Inclusion Criteria

My heart's pumping ability is classified as reduced or preserved.
My pulmonary vascular resistance is 2.5 WU or higher.
I have heart failure classified as moderate to moderately severe.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JK07 high dose via intravenous infusion

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • JK07

Trial Overview

The study is testing JK07's safety, tolerability, and effectiveness in patients with heart failure and cpcPH. It's an open-label Phase 2a trial where all enrolled participants will receive a high dose of JK07 over multiple doses.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: JK07 high doseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Salubris Biotherapeutics Inc

Lead Sponsor

Trials
5
Recruited
710+

Citations

Study of JK07 in Patients With Heart Failure and WHO ...

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 ...

Salubris Biotherapeutics Provides Updates on JK07 and ...

Company initiated RENEU-PH, Phase 2a study of JK07 in patients with Group 2 pulmonary hypertension and heart failure. Phase 1 dose escalation ...

Study of JK07 in Patients With Chronic Heart Failure

This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants ...

Salubris Biotherapeutics Provides Updates on JK07 and ...

The primary endpoint of the study for the HFrEF cohort is change in left ventricular ejection fraction (LVEF) at 26 weeks. The HFrEF cohort ...

Preclinical Evaluation of the Safety and Activity of JK07, A ...

... effective as NRG-1 in improving LVEF and symptoms. In a spontaneous heart failure model in rhesus macaques, JK07 treatment was comparable to ...

Phase 2 Study of JK07 in Chronic Heart Failure

The purpose of this study is assess the safety and effficacy of JK07 in Adults With Chronic Heart Failure.