NCT01842516已完成1 期
A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability, and Population Pharmacokinetics 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
- 30
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Primary
- To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
- To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral dose in healthy male subjects
- To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male subjects
详细描述
- To investigate the PK characteristics of LCB01-0371 after a multiple oral dose
- To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health Male between 20 and 45 years of age at the time of screening and a subject with body mass index (BMI) between 19 and 27
- •Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
- •Able to donate blood during study period and follow visit.
- •Agree to continue to use a reliable method of birth control until 60 days after study completion.
- •Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
排除标准
- •History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
- •History of gastrointestinal problem 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 drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.
研究组 & 干预措施
LCB01-0371 800mg
Experimental
LCB01-0371 800mg
干预措施: LCB01-0371 800mg (Drug)
LCB01-0371 1200mg
Experimental
LCB01-0371 1200mg
干预措施: LCB01-0371 1200mg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 7 days
次要结局
- Area under the plasma concentration versus time curve (AUC) of LCB01-0371(Up to 7 days)
- Peak Plasma Concentration (Cmax) of LCB01-0371(Up to 7 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose StudyHealthyNCT01554995LigaChem Biosciences, Inc.70
终止
1 期
An Open-label, Single Dose, Parallel Design, Phase 1 Clinical Study of LCB01-0371HealthyNCT02529241LigaChem Biosciences, Inc.12
已完成
1 期
Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371HealthyNCT02540460LigaChem Biosciences, Inc.30
已完成
1 期
DP13 SAD & MAD in Healthy Male SubjectsSafety and TolerabilityNCT03046589Damian Pharma AG48
已完成
1 期
PF-06669571 In Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseNCT02565628Pfizer20