NCT03196804已完成1 期
A Dose Blocked-randomized, Double-blind, Placebo-controlled, Multiple Dosing and Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects
LG Chem1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年6月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple iv injection in healthy male subjects.
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 19 and 45 years at screening.
- •Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive)
排除标准
- •Participation in a clinical research study within the previous 3 months
- •Regular alcohol consumption >21 units per week.
研究组 & 干预措施
LC28-0126
Experimental
LC28-0126(IV)
干预措施: LC28-0126 (Drug)
Placebo
Placebo Comparator
Placebo of LC28-0126
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events
时间窗: 18 days
次要结局
- Cmax(up to 6 days post-dose)
- AUC(up to 6 days post-dose)
研究者
研究点 (1)
Loading locations...
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