NCT05322616

Single-Ascending Dose Study of JK07 in Subjects With HFpEF

A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Assess the Safety and Tolerability of JK07 in Subjects With Heart Failure With Preserved Ejection Fraction (HFpEF)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Salubris Biotherapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A phase 1, randomized, double-blind, placebo-controlled single-ascending dose study to assess JK07 in adult subjects with heart failure with preserved ejection fraction.

Detailed description

A phase 1, randomized, double-blind, placebo-controlled single-ascending dose study to assess the safety and tolerability of JK07 in subjects 18 to 85 years of age with heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction \>=45%. Eligible subjects must have maintained an optimal heart failure medical regimen for at least 1 month prior to informed consent, other than for diuretics, and as much as clinically appropriate, remain on the treatment regimen throughout the course of the study. Initially 5 dose escalation cohorts are planned with the option of expansion to 7 dose escalation cohorts. Eight subjects will be randomized in a 6:2 ratio of JK07:placebo in each cohort. The initial dose and dose escalation parameters will be dependent on the JK07.1.01 study Only doses established as safe in Study JK07.1.01 will be evaluated in this study and the highest JK07 dose administered will not exceed the lower of the top dose evaluated in Study JK07.1.01 or 2.5 mg/kg without amending the protocol. Subjects will be observed in a hospital or similar setting from prior to study drug infusion to completion of study assessments on Day 1. Subjects will undergo blood sampling for clinical laboratory evaluation, including glucose fingerstick, and biomarkers, electrocardiogram, 2-dimensional transthoracic echocardiography, quality of life assessment and a a 6-minute walking test. Follow-up assessments will be performed at Day 2, 7, 15, 28, 60, 90, and 180.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DRUG	JK07	Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
DRUG	Matching Placebo	Vehicle control

Timeline

• Start date: 2022-10-21
• Primary completion: 2023-05-26
• Completion: 2023-05-26
• First posted: 2022-04-12
• Last updated: 2023-05-31

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study