Systolic Heart Failure Clinical Trial
Official title:
A Phase 1b, Randomized, Double-Blinded, Dose Escalation, Single Center, Repeat-Dose Safety and Pharmacodynamics Study of Orally Administered Dapansutrile Capsules in Subjects With NYHA II-III Systolic Heart Failure
This is a Phase 1b randomized, double-blinded, single-center safety and pharmacodynamics
study of sequential cohort, dose-escalating, repeat-dosing of dapansutrile or placebo (4:1
ratio) in subjects with stable systolic heart failure (HF) with LVEF≤40% symptomatic for NYHA
functional classification II-III who show signs of systemic inflammation (high sensitivity
plasma C reactive protein [hsCRP] > 2 mg/L). A total of 30 subjects will be enrolled in 3
sequential cohorts by randomized allocation (8 active and 2 placebo within each cohort).
Progression to cohort 2 with dose escalation will occur following the Day 28 visit of the
last subject in the first cohort. Progression to cohort 3 with dose escalation will occur
following the Day 8 visit of the last subject in the second cohort.
Subjects will be screened and evaluated twice for eligibility: 1) at the time of Screening
(up to 28 days prior to enrollment); and 2) at the Baseline visit, prior to randomization.
Following enrollment, Baseline assessments will be conducted and the first dose of
investigational product (either dapansutrile capsules or placebo capsules) will be
administered at the clinical site upon completion of all assessment and collection of
baseline parameters. Subjects will then self-administer investigational product once, twice
or four times daily, depending on cohort, for up to fourteen (14) consecutive days beginning
at the Baseline visit and continuing through the planned Day 14 visit. Subjects will return
to the study clinic on Days 4, 8, 14 and 28 for follow-up visits. Additionally, subjects will
be contacted for telephone follow-up on Day 42.
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