jRCT2071230075已完成不适用
A Randomised, Single-blind, Single-centre, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Subcutaneous Dose Administration in Healthy Japanese Participants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- AEs and SAEs
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 60age old under（—）
- 性别
- All
入选标准
- •1 Participants must be 18 to 60 years of age inclusive, at the time of signing the informed consent.
- •2 Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •3 Participants who are of Japanese ethnicity
- •A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan.
- •4 Participants must have suitable veins for cannulation or repeated venepuncture.
- •5 Body mass index within the range 18 to 32 kg/m2 (inclusive) and weigh at least 50 kg.
- •6 Males and/or females
- •Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •1 As judged by the investigator, any evidence of any clinically important disease or disorder which, in the investigator's opinion makes it undesirable for the participant to participate in the study.
- •2 History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- •3 Participants with known autoimmune disease or on-treatment with immune modulatory drugs.
- •4 Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
- •5 Any clinically significant cardiovascular event within last 6 months prior to the Screening Visit.
- •6 Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results, including participants with platelet or bleeding disorders, and known platelet dysfunction disorders as judged by the investigator.
- •7 Any positive result at the Screening Visit for serum HBsAg, hepatitis C antibody and HIV.
- •8 Confirmed COVID-19 infection during screening as per local guidelines.
- •9 Abnormal vital signs, after 10 minutes supine rest at the Screening Visit and/or Day-1
- •20 Participation in another clinical study with a study intervention administered in the last 3 months prior to randomisation.
- •27 Previous randomisation in the present study.
结局指标
主要结局
AEs and SAEs
Adverse Events and Serious Adverse Events
12-lead safety ECGs, dECGs, and telemetry
12-lead safety electrocardiograms, digital electrocardiograms, and telemetry
Vital signs
Vital signs (including blood pressure, pulse rate, and body temperature)
Physical examination
Physical examination
ISRs
Injection Site Reactions
Clinical laboratory evaluations
Clinical laboratory evaluations (haematology, including platelet count, clinical chemistry, and coagulation, renal safety biomarkers, immune activation response, complement activation panel, and urinalysis)
次要结局
未报告次要终点
研究者
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