A Phase I Clinical Study, Multiple Dose of LCB01-0371 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- No of Adverse events
研究概览
简要总结
The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371 after a multiple oral dose in healthy male subjects.
To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male subjects.
详细描述
Double blind, randomized, placebo control, multiple dose, dose escalation study
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
- Double (Participant, Investigator)
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 kg/m2 and 27 kg/m2 at the time of screening
- •Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after 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, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s)
- •History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
- •History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or 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
- •AST, ALT, r-GT, bilirubin(total) values over than 1.5 times of ULN
研究组 & 干预措施
LCB01-0371 800mg BID
LCB01-0371 800mg BID
干预措施: LCB01-0371 800mg BID (Drug)
LCB01-0371 1200mg BID
LCB01-0371 1200mg BID
干预措施: LCB01-0371 1200mg BID (Drug)
LCB01-0371 800mg BID
LCB01-0371 800mg BID
干预措施: Placebo (Drug)
LCB01-0371 800mg
LCB01-0371 800mg
干预措施: LCB01-0371 800mg (Drug)
LCB01-0371 800mg
LCB01-0371 800mg
干预措施: Placebo (Drug)
LCB01-0371 1200mg BID
LCB01-0371 1200mg BID
干预措施: Placebo (Drug)
Placebo
LCB01-0371 800mg, LCB01-0371 800mg BID, LCB01-0371 1200mg BID
干预措施: Placebo (Drug)
结局指标
主要结局
No of Adverse events
时间窗: From date of randomization until follow up after 3 days from last hospital discharge
次要结局
- Pharmacokinetics: Cmax(Peak plasma concentration)(0(predose), 0.5, 1, 2, 4, 8 and 12hours)
- Pharmacokinetics: AUC(Area under the curve)(0(predose), 0.5, 1, 2, 4, 8 and 12hours)