A Phase 1, Single-center, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC0-last: the area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration
研究概览
简要总结
This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects.
The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85.
A total of 24 healthy subjects will be enrolled in 3 dose groups (n=8 per dose group) and randomized to either LEO 138559 or placebo in a ratio of 6:2.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older 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
LEO 138559 Dose 2
LEO 138559 will be administered subcutaneously up to 3 injections per dosing
干预措施: LEO 138559 (Drug)
LEO 138559 Dose 1
LEO 138559 will be administered subcutaneously up to 3 injections per dosing
干预措施: LEO 138559 (Drug)
LEO 138559 Dose 3
LEO 138559 will be administered subcutaneously up to 3 injections per dosing
干预措施: LEO 138559 (Drug)
Placebo
LEO 138559 placebo will be administered subcutaneously up to 3 injections per dosing
干预措施: LEO 138559 Placebo (Drug)
结局指标
主要结局
AUC0-last: the area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration
时间窗: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
AUC0-inf: area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time
时间窗: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
Cmax: maximum serum LEO 138559 concentration
时间窗: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
tmax: time of maximum serum LEO 138559 concentration
时间窗: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
t½: terminal elimination half-life
时间窗: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
CL/F: apparent total body clearance
时间窗: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
Vz/F: apparent volume of distribution
时间窗: From Day 1 to Day 85
Pharmacokinetic endpoint to be determined from serum concentrations
次要结局
- Number of treatment emergent adverse events(From Day 1 to Day 85)
- Presence of binding anti-drug antibodies(Day 1(pre-dose), Day 29, Day 57, and Day 85)