Study to Assess the Safety, Tolerability, and Pharmacokinetics (Movement of Drugs Within the Body) of AZD2693 in Healthy Japanese Participants

Hibi Kazushige0 个研究点目标入组 22 人开始时间: 2021年11月24日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 22

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 <= 60age old（—）
性别: All

入选标准

•Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
•- Participants who are of Japanese ethnicity (Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese and this also includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan)
•- Participants who are of Non-Asian ethnicities. A Non-Asian Participant is defined as having both parents and grandparents who are ethnically Non-Asian
•- Body mass index within the range 18 to 32 kg/m^2
•- Male and/or female participants of non-child bearing potential

排除标准

•- History of any clinically important disease or disorder
•- History or presence of gastrointestinal, hepatic, or renal disease or condition known to interfere with absorption, distribution, metabolism or excretion of drugs
•- Participants with known autoimmune disease or on-treatment with immune-modulatory drugs
•- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first dose of study intervention
•- Any clinically significant cardiovascular event within the last 6 months prior to the Screening Visit
•- Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results and any abnormal vital signs
•- Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-Lead ECG
•- Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding
•- History of major bleed or high-risk of bleeding diathesis
•- Participants with a positive diagnostic nucleic acid test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), at Screening Visit. Participants who test positive for Coronavirus disease 2019 (COVID-19) at Screening Visit
•- Participants with a significant COVID-19 illness within 6 months of enrollment
•- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
•- Received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days of last Follow-up to first dose of study intervention of this study or 5 half-lives from last dose to first dose of study intervention, whichever is the longest
•- Participants who have previously received AZD2693
•- Previous enrollment or randomization into the present study

研究者

发起方

Hibi Kazushige

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