Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
Status:
Recruiting
Trial end date:
2022-03-15
Target enrollment:
Participant gender:
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.