NCT01991509已完成1 期
A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study Assessing the Safety, Tolerability and Pharmacokinetics of Two Different Doses of LBR-101 Given Intravenously and Subcutaneously
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Relative bioavailability of IV versus SC Administration of LBR-101
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101 when administered intravenously or subcutaneously to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally Healthy, Signed Approved Informed Consent, BMI 17.5-34.5 kg/m2, Willing and able to comply with CRU rules regulations and study schedule
排除标准
- •Clinically significant medical or psychiatric condition, Febrile illness within 5 days of dosing, Pregnant or Nursing Females. History of alcoholism, drug addiction or positive drug/alcohol screen, History of hypersensitivity to injected proteins or monoclonal antibodies, Unwilling or unable to comply with the protocol specified lifestyle guidelines, Investigational site staff members, Use of 3 or more prescription or non-prescription medications daily, Acetaminophen use in doses of higher than 1 g or more/day, Daily Aspirin use in higher than 325 mg/day, Treatment with an investigational drug within 30 days of dosing, Use of biologics within 6 months of screening, Any clinically significant abnormality in the 12-Lead ECG, Positive result for HIV, Hepatitis B, or Hepatitis C, Any clinically significant abnormalities in Blood Chemistry Hematology or Urinalysis, Positive Pregnancy Test.
结局指标
主要结局
Relative bioavailability of IV versus SC Administration of LBR-101
时间窗: 30 Days
次要结局
未报告次要终点
研究者
研究点 (2)
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