A Single-blind, Randomized, Placebo Controlled, Parallel-group, Adaptive-design Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 Administered Intranasally for up to 7 Days, on the Biomarker
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
研究概览
简要总结
The study will investigate how the dose of AZD8848 and the dosing frequency will affect the immunological/inflammatory response by measuring the production of biomarkers in blood and nasal lavage.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men or women aged 18 to 55 years (inclusive). Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method, with additional use of a condom by male partners, until 3 months after last dose.
- •Female subjects should have a negative pregnancy test at Visit 2 and date of last menstruation consistent of non-pregnancy
- •Ability to metabolise AZD8848 (an in vitro screening assay will determine metabolic activity in a blood sample taken at Visit 1 using a pre-defined limit)
排除标准
- •Any clinically significant disease or disorder
- •Any clinically relevant abnormal findings in physical examination
- •Structural abnormalities of the nose or nasal disorder symptomatic enough to cause significant nasal obstruction
- •Ongoing pregnancy or lactation
- •Abnormal immune function
研究组 & 干预措施
1
Placebo given once daily on 7 days
干预措施: Placebo (Drug)
2
Active treatment at Day 1 and Day 7. Placebo on Day 2, 3, 4, 5 and 6
干预措施: AZD8848 (Drug)
2
Active treatment at Day 1 and Day 7. Placebo on Day 2, 3, 4, 5 and 6
干预措施: Placebo (Drug)
3
Active treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6.
干预措施: AZD8848 (Drug)
3
Active treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6.
干预措施: Placebo (Drug)
4
Active treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6.
干预措施: AZD8848 (Drug)
4
Active treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6.
干预措施: Placebo (Drug)
5
Active treatment once daily on 7 days
干预措施: AZD8848 (Drug)
结局指标
主要结局
CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage
时间窗: Samples collected pre-dose and 12-14 days after first dose.
次要结局
- To assess safety and tolerability of intranasal administration of AZD8848 at different doses and dosing regimens(During the 7 days dosing period and at four follow-up visits up to 11-13 months after the last dose)