JK07 for Heart Failure and Pulmonary Hypertension

(RENEU-PH Trial)

Overseen By Ashleigh Chasteen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Salubris Biotherapeutics Inc

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

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?

Group I: JK07 high dose Experimental Treatment 1 Intervention

JK07 administered by intravenous (IV) infusion

Who Is Running the Clinical Trial?

Salubris Biotherapeutics Inc

Lead Sponsor

Trials

5

Recruited

710+