NCT01096563终止1 期
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 After Administration of Single and Multiple Ascending Doses for 13 Days in Healthy Male and Female Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
研究概览
简要总结
This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after administration of single and Multiple Ascending doses in Japanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese subjects with suitable veins for cannulation or repeated venipuncture
- •Have a body mass index (BMI) between 18 and 27 kg/m2 and a body weight between 50 and 85 kg
- •Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
研究组 & 干预措施
1
Experimental
AZD9164
干预措施: AZD9164 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
时间窗: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
次要结局
- To investigate the pharmacokinetics (PK) of AZD9164 following inhaled administration of single and multiple ascending doses, by assessment of the dose proportionality, the degree of accumulation and the time linearity(PK sampling during the residential period and intense PK sampling on day 1 and day 15 (up to 72 and 120 hours respectively))
- To investigate pharmacodynamic (PD) effects of inhaled single and multiple ascending doses of AZD9164, by assessment of lung function(Spirometry during the residential stay on days 1, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
AZD2423 Single Ascending Dose Study in Healthy Japanese SubjectsHealthy VolunteerNCT00970775AstraZeneca32
已完成
1 期
AZD1386 Japanese Multiple Ascending Dosing StudyChronic PainNCT00736658AstraZeneca32
已完成
1 期
Tezepelumab Phase 1 PK Study in Healthy Chinese SubjectsHealthy SubjectsNCT04362410AstraZeneca48
已完成
1 期
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese SubjectsHealthy VolunteersNCT04466748Sihuan Pharmaceutical Holdings Group Ltd.36
已完成
1 期
A Multiple Ascending High Dose Pharmacology Study of Anaprazole in Healthy Chinese SubjectsHealthy VolunteersNCT04471922Sihuan Pharmaceutical Holdings Group Ltd.45