Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study to assess the safety, tolerability, immunogenicity, PK, and exploratory efficacy of JK07 in subjects 18 to 80 years of age with HFrEF ≤40%. Initially 5 cohorts are planned with the option to expand the study to a total of 7 cohorts. The size of the cohorts will range from 5 to 9 subjects. Each cohort will include one single active unblinded sentinel subject receiving a single IV dose of JK07 prior to randomized single dose administration of JK07 or placebo \[3:1\] in the remainder of the cohort.

Timeline

Start

2020-09-21

Primary completion

2023-06-08

Completion

2023-07-07

Publications

• Tang WHW, Steiner J, Kassi M, Wheeler MT, Spahillari A, Sweitzer NK, Grodin JL, Solomon N, Singhal S, McEwen AMG, Murphy SL. Single Ascending-Dose Study of Selective ErbB4 Agonist JK07 in Heart Failure With Reduced Ejection Fraction. JACC Basic Transl Sci. 2025 Sep;10(9):101352. doi: 10.1016/j.jacbts.2025.101352. Epub 2025 Jul 29.

Drugs

Indications