NCT02134834已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously 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
- 40
- 主要终点
- Safety from baseline through the end of the study
研究概览
简要总结
The objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.
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)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian males aged between 18 and 45 years (inclusive) at Screening
- •A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening
- •Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests
- •Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1
排除标准
- •Receipt of any investigational agent or drug within four months before Screening
- •A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria
- •Hypersensitivity and/or allergy to drugs
- •Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders
- •A history of chronic or recurrent infections or current active infection
- •A recent history of surgery within three months prior to Screening, determined by the Investigator to be clinically relevant
- •A history or presence of malignancy
- •Donation of blood (or loss of blood) greater than 400 ml within three months before Screening
- •A history of smoking at any time within one year before Screening
研究组 & 干预措施
Ascending single dose of OP0595
Experimental
干预措施: OP0595 (Drug)
Normal Saline
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety from baseline through the end of the study
时间窗: Day 1 to Day 7
Number of patients with adverse events
次要结局
- Urine PK parameters of OP0595 and its metabolites(Day 1 to Day 2)
- Plasma PK parameters of OP0595 and its metabolites(Day 1 to Day 2)
研究者
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