NCT01554995已完成1 期
A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCB01-0371 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- safety and tolerability
研究概览
简要总结
Primary
- To investigate the safety and tolerability of LCB01-0371 after a single oral dose
Secondary
- To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose
- To investigate the safety of LCB01-0371 after a single oral dose
详细描述
- To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose
- To investigate the safety of LCB01-0371 after a single oral dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Male between 20 and 45 years of age at the time of screening
- •Subjects with body mass index (BMI) between 20 and 27 at the time of screening
- •Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days of study completion
- •Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements
排除标准
- •History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
- •History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption within 6 months from screening
- •History of hypersensitivity or clinically significant adverse drug reaction(s) to the LCB01-0371, same class of the study drugs (linezolid), or other drugs including aspirin and antibiotics.
- •History of drug abuse or positive result at urine drug screening test
- •AST, ALT, r-GT, billirubin(total) values over than 1.5 times of ULN
研究组 & 干预措施
LCB01-0371
Experimental
active
干预措施: LCB01-0371 (Drug)
Linezolid
Experimental
comparator
干预措施: Linezolid (Drug)
结局指标
主要结局
safety and tolerability
时间窗: 7 days
Summary statistics for SAD parts will be prepared for measured values and changes from baseline values for each dose group. Placebo subjects will serve as the control. Summaries of treatment-emergent and clinically important abnormalities in ECG, physical examination, vital signs, and laboratory (clinical chemistry, hematology, coagulation, urinalysis) data will be provided. The incidence of adverse events(AEs) will be tabulated and compared across dose group in the SAD parts.
次要结局
未报告次要终点
研究者
研究点 (1)
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