A Phase I, Randomized, Double Blind, Placebo Controlled 2-Parts Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD4205 Following Single and Multiple Ascending Dose in Healthy Adult Subjects, and to Assess the Effect of Food on the Pharmacokinetics of AZD4205
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The number of subjects with abnormal vital signs
研究概览
简要总结
This study is to assess the safety, tolerability, pharmacokinetics of AZD4205 following single and multiple ascending dose in healthy adult subjects, and to assess the effect of food on the pharmacokinetics of AZD4205.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able to understand the nature of the trial and provide a signed and dated, written informed consent form prior to any study specific procedures, sampling and analyses.
- •Female and/or male aged ≥18 ~ ≤ 45 years, with BMI ≥18~≤ 28kg/m
- •Female subjects must have negative pregnancy tests at screening and check-in AND: have been surgically sterile OR post-menopausal OR, if of child-bearing potential, must be using an acceptable method of contraception.
- •Male subjects must be surgically sterile or using an acceptable method of contraception during the study and for 6 months after the last dose of AZD4205 or matching placebo to prevent pregnancy with a partner.
排除标准
- •Evidence or reported history of clinically significant hematological (absolute neutrophil count < 1.5 x 10^3/μL; platelet count < 100 x 10^3/μL; hemoglobin < 9 g/dL, INR > 1.5), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease determined by the investigator.
- •Received a live vaccine within 3 months before first dose of IP.
研究组 & 干预措施
AZD4205
Single ascending dose: 5mg, 20mg, 50mg, 100mg, 150mg Multiple ascending dose: low, medium and high dose once daily X 14 days
干预措施: AZD4205 (Drug)
Placebo
placebo single dose in SAD and once daily for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
The number of subjects with abnormal vital signs
时间窗: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal vital signs
The number of subjects with abnormal laboratory parameters
时间窗: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal laboratory parameters
The number of subjects with adverse events
时间窗: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of adverse events (AEs)
The number of subjects with abnormal electrocardiogram
时间窗: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal electrocardiogram
次要结局
未报告次要终点