A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males aged 20 to 40 years at screening.
- •Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.
排除标准
- •History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
- •History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
- •History of known hypersensitivity to drugs including CTB-001
研究组 & 干预措施
CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose
干预措施: CTB-001 (Drug)
CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose
干预措施: CTB-001 (Drug)
CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose
干预措施: CTB-001 (Drug)
CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation
干预措施: CTB-001 (Drug)
结局指标
主要结局
Safety
时间窗: Up to 7 hours
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