NCT03174613已完成1 期
A Dose Blocked-randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamics and Food Effect of LC51-0255
LG Chem1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年5月31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
- 100
- 试验地点
- 1
- 主要终点
- MTD determination
研究概览
简要总结
- To evaluate the safety and tolerability of LC51-0255 in healthy male subjects
- To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects
- To evaluate bioavailability of LC51-0255
详细描述
For safety and tolerability assessement, subjects will be monitored by collection of adverse events, physical exams, vital sign, 12-Lead ECG, Continuous ECG monitoring, Holter monitoring, blood chemistry and hematology panels, pulmonary function tests, optical coherence tomography (OCT) during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 aged 19~45 years at screening.
- •Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive)
排除标准
- •History or Known presence of clinically relevant hepatic, gastrointestinal, pulmonary, psychiatric, endocrine, neurological, cancer, including solid tumors and hematological malignancies, cardiovascular, ophthalmological or other major systemic disease
- •Exclusions Related to Laboratory Results: Platelet count < 100,000/μL, Hgb < 8.5 g/dL, Neutrophils < 1.5 /μL, Absolute WBC count < 3500/μL, Absolute lymphocyte count < 800/μL
研究组 & 干预措施
LC51-0255
Experimental
tablets, PO
干预措施: LC51-0255 (Drug)
Placebo
Placebo Comparator
tablets, PO
干预措施: Placebo (Drug)
结局指标
主要结局
MTD determination
时间窗: Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study
Safety and Tolerability
次要结局
- Pharmacokinetic: Peak Plasma Concentration (Cmax)(Cmax:168 hours post dose)
- Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)(AUCinf:168 hours post dose)
研究者
研究点 (1)
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