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Clinical Trial Summary

Part A of this study is a Phase 1, First-in-human (FiH), randomized, single-blind, placebo controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD3366 following single intravenous (IV) ascending doses. Part B of this study is a randomized, single blind, parallel group placebo- controlled study to assess the safety, tolerability and PD of a single IV administration of AZD3366 with concomitant loading doses followed by repeated maintenance dosing of ticagrelor and acetylsalicylic acid (ASA).

Clinical Trial Description

The study will provide data on safety, tolerability, PK, and PD of AZD3366 in healthy male and female subjects. Up to 72 healthy volunteers (48 in Part A and 24 in Part B) and 10 Japanese subjects will be randomized into the study. This study will be conducted at a single study center in United States of America (USA). Part A of the study will investigate the safety, tolerability, PK, and PD (inhibition of platelet aggregation and capillary bleeding time [CBT]) of an IV administration of single ascending doses (SAD) of AZD3366 in male and female non-Asian healthy volunteers and Japanese subjects. Part B of the study will investigate the safety, tolerability, and PD (inhibition of platelet aggregation and CBT) of a single IV dose of AZD3366 or placebo with concomitant administration of ticagrelor and ASA by a parallel group cohort consisting of male and female healthy volunteers. Furthermore, the potential effect of AZD3366 on the PK of ticagrelor will be investigated. Co-medication with ASA and ticagrelor is chosen based on the Standard of Care anti-platelet treatment regimen in patients with myocardial infarction. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04588727
Study type Interventional
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email [email protected]
Status Recruiting
Phase Phase 1
Start date October 15, 2020
Completion date January 3, 2022

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