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Clinical Trial Details

Trial ID: L0540
Source ID: NCT06675175
Associated Drug: Azd4144
Title: A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Atherosclerotic Cardiovascular Disease
Interventions: DRUG: AZD4144|OTHER: Placebo
Outcome Measures: Primary: Number of participants with adverse events, The safety and the tolerability of AZD4144 compared with placebo will be evaluated., 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., Day 1 to Day 28 | Secondary: 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., 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., 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., 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., Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-16
Completion Date: 2025-08-08
Results First Posted:
Last Update Posted: 2025-04-10
Locations: Research Site, Glendale, California, 91203, United States|Research Site, Daytona Beach, Florida, 32117, United States|Research Site, Jacksonville, Florida, 32216, United States|Research Site, Miami, Florida, 33125, United States|Research Site, Port Orange, Florida, 32127, United States|Research Site, Tampa, Florida, 33603, United States|Research Site, Farmington Hills, Michigan, 48334, United States|Research Site, Bronx, New York, 10455, United States|Research Site, Sherman, Texas, 75092, United States|Research Site, Pleven, 5800, Bulgaria|Research Site, Sofia, 1407, Bulgaria|Research Site, Sofia, 1527, Bulgaria|Research Site, Sofia, 1709, Bulgaria|Research Site, Budapest, 1083, Hungary|Research Site, Gyöngyös, 3200, Hungary|Research Site, Kistarcsa, 2143, Hungary|Research Site, Bucharest, 11658, Romania|Research Site, Cluj Napoca, 400006, Romania|Research Site, Timisoara, 300732, Romania
URL: https://clinicaltrials.gov/show/NCT06675175

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress