A Phase 1, Single Centre, Double-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Tezepelumab After Single-Dose Subcutaneous Administration in Healthy Chinese Subjects (DIRECTION-CK)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUC0-t (Area under the serum concentration versus time curve from time zero to the last quantifiable concentration)
研究概览
简要总结
This is a Phase 1, Single Centre, Double-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Tezepelumab after Single-Dose Subcutaneous Administration in Healthy Chinese Subjects.
详细描述
This is a Phase 1, single centre, randomized, double-blind, placebo-controlled, single dose, parallel group study in healthy Chinese male or female subjects. 48 healthy subjects will be randomly assigned to one of the three treatment cohorts (i.e. 1:1:1 to Low dose, Medium dose and High dose) to receive a single dose of tezepelumab or placebo in a 3:1 ratio. Each subject will only participate in one cohort. Dose level is unblinded and treatment (tezepelumab or placebo) will be double-blinded within each treatment cohort. Following a screening period of a maximum of 28 days, subjects will stay at the study facility for two nights starting from the day before dosing (Day -1) to Day 2. Subjects will receive a single dose of tezepelumab or placebo subcutaneously on Day 1 and safety monitoring and serial collection of blood samples for PK evaluation will be followed throughout the study period. The follow up period after the dosing will be 112 days.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
double-blinded
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
- •Male and female healthy Chinese subjects
- •Age 18 to 45
- •Body weight ≥ 40 kg
- •Body mass index (BMI) between 19-24 kg/m2
排除标准
- •History or evidence of a clinically significant disorder
- •History of cancer
- •Smokers of > 5 cigarettes/day
- •Receipt of any marketed or investigational biologic within 4 months or 5 half-lives/non-biologic agent within 30 days or 5 half-lives prior to randomization
- •History of chronic alcohol or drug abuse
- •Hepatitis B, C or HIV
- •Pregnant or breastfeeding
- •History of anaphylaxis following any biologic therapy
结局指标
主要结局
AUC0-t (Area under the serum concentration versus time curve from time zero to the last quantifiable concentration)
时间窗: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Cmax (Maximum serum concentration)
时间窗: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
AUC0-inf (Area under the serum concentration versus time curve from time zero to Infinity)
时间窗: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Vz/F (apparent volume of distribution)
时间窗: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
tmax (time to Cmax)
时间窗: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
t1/2 (terminal serum half-life)
时间窗: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
CL/F (apparent serum clearance)
时间窗: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
次要结局
- Immunogenicity anti-drug antibodies(Blood samples will be collected on Day 1 (3 hour prior to administration of IP) and on Day 29, Day 113.)