A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-ascending Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of MEDI3506 in Healthy Chinese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
This study is to evaluate the pharmacokinetics, immunogenicity, safety and tolerability of investigational drug MEDI3506 with single dose in Healthy Chinese participants.
详细描述
A phase I, randomised, double-blind, placebo-controlled parallel-group study to evaluate the pharmacokinetics, immunogenicity, safety, and tolerability of single dose of MEDI3506 in healthy Chinese Participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MEDI3506 dose 1
MEDI3506 dose1
干预措施: MEDI3506 (Biological)
MEDI3506 dose 2
MEDI3506 dose 2
干预措施: MEDI3506 (Biological)
Placebo
Placebo 2 mL and 4 mL
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Day 1 to Day 113
To assess the maximum plasma concentration of MEDI3506 after single subcutaneous administrations in healthy Chinese participants.
Time to reach maximum observed concentration (tmax)
时间窗: Day 1 to Day 113
To assess the MEDI3506 time to reach peak serum concentration after single subcutaneous administration of MEDI3506 in healthy Chinese participants.
Area under the serum concentration time curve to the last observation(AUC0-t)
时间窗: Day 1 to Day 113
To assess the area under the serum concentration time curve from pre-dose until the last observation quantified after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Apparent volume of distribution based on terminal phase (Vz/F)
时间窗: Day 1 to Day 113
To assess the apparent volume of distribution of MEDI3506 after single subcutaneous administration of MEDI3506 in healthy Chinese participants
Area under the serum concentration time curve to the infinite (AUC0-inf)
时间窗: Day 1 to Day 113
To assess the area under the serum concentration time curve from pre-dose until infinite after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Terminal Elimination half-life (t1/2)
时间窗: Day 1 to Day 113
To assess the terminal elimination half-life after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Apparent total body Clearance (CL/F)
时间窗: Day 1 to Day 113
To evaluate the apparent MEDI3506 total body clearance from serum after single subcutaneous administration of MEDI3506 in healthy Chinese participants
次要结局
- Immunogenicity determined by incidence of ADA(Day 1 (-30~0 min before IP administration), and on Day 8, Day 29, Day 57, Day 85 and Day 113)
- Immunogenicity determined by prevalence of antidrug antibodies (ADA)(Day 1 (-30~0 min before IP administration), and on Day 8, Day 29, Day 57, Day 85 and Day 113)