A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, and Safety of Mavrilimumab in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- PK profile of mavrilimumab
研究概览
简要总结
A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity of single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.
详细描述
This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group, single-dose study to evaluate the PK, immunogenicity, and safety of mavrilimumab at doses of 100 and 150 mg in healthy adult Japanese subjects. The study will be conducted at one site in Europe and subjects will be randomized in a 5:5:2 ratio to 100, 150mg mavrilimumab and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is of Japanese ethnicity
- •No evidence of clinically significant respiratory disease
排除标准
- •Any condition that, would interfere with the evaluation of the study drug or safety of subjects.
- •Subject has a known hypersensitivity to any components of the investigational product.
- •History of infection requiring hospitalization or treatment with IV antibiotics within 12 weeks before screening, or evidence of clinically significant active infection.
- •Subject has a history or present condition of malignancy.
- •Subject has a history or presence of drug addiction (urine test) or has alcohol consumption (breath test) of more than 21 (males) or 14 (females) units of alcohol per week.
- •Any blood donation or significant loss of blood within 56 days of study initiation,
- •Receipt of live (attenuated) vaccine within the 4 weeks before screening or during the study.
研究组 & 干预措施
100mg arm
100mg dose
干预措施: 100mg Mavrilimumab (Drug)
150mg arm
150mg dose
干预措施: 150mg mavrilimumab (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
PK profile of mavrilimumab
时间窗: from dosing to day 85
•Non-compartmental PK parameters following a single-dose of mavrilimumab to analyse •Maximum observed concentration (Cmax); area under the concentration-time curve (AUC); time to maximum concentration (Tmax) and half-life (t1/2) from dosing to Day 85 •The number and percentage of subjects that are ADA positive will be summarized by dose
次要结局
- To evaluate the safety of mavrilimumab(from dosing to day 85)