The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD).
This is a Phase 1b, randomized, double blind, placebo-controlled study and will be conducted in participants with established ASCVD and CKD with persistent inflammation (High-sensitivity C-reactive protein \[hsCRP\] \> 2 mg/L and eGlomerular filtration rate \[eGFR\] ≥ 30 to \< 60 mL/min/1.73m2). The participants will be randomized in the 1:1 ratio to either receive treatment with AZD4144 or placebo. The study will be comprised of: * A screening period of 28 days * Treatment period where each participant will either receive oral dose of AZD4144 or placebo for 28 days. * A follow-up visit (Day 35 ±1) and a Final Follow-up (on Day 56±1) post first dose administration. The total duration of the study will be approximately 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
29
Research Site
Glendale, California, United States
Research Site
Daytona Beach, Florida, United States
Research Site
Jacksonville, Florida, United States
Number of participants with adverse events
The safety and the tolerability of AZD4144 compared with placebo will be evaluated.
Time frame: From first dose (Day 1) until Follow-up (Day 56±1)
Relative change from baseline to 4 weeks in systemic Interleukin-6 (IL-6) levels
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be evaluated.
Time frame: Day 1 to Day 28
Relative change from baseline to 4 weeks in systemic IL-18 and High-sensitivity C-reactive protein (hsCRP) levels
The effect of AZD4144 on circulating inflammatory biomarkers IL-18 and hsCRP compared with placebo will be evaluated.
Time frame: Day 1 to Day 28
Maximum plasma drug concentration (Cmax)
The Cmax after administration of AZD4144 in participants with ASCVD and CKD will be evaluated.
Time frame: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
Time to reach maximum observed concentration (tmax)
The tmax after administration of AZD4144 in participants with ASCVD and CKD will be evaluated.
Time frame: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
Observed lowest concentration before the next dose is administered (Ctrough)
The Ctrough after administration of AZD4144 in participants with ASCVD and CKD will be evaluated.
Time frame: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
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Research Site
Miami, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
The Bronx, New York, United States
Research Site
Sherman, Texas, United States
Research Site
Pleven, Bulgaria
...and 5 more locations