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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 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.
研究组 & 干预措施
LBR-101 IV Dose 1
Experimental
LBR-101 Dose 1 Administered Intravenously
干预措施: LBR-101 IV (Biological)
LBR-101 SC Dose 1
Experimental
LBR-101 Dose 1 Administered Subcutaneously
干预措施: LBR-101 SC (Biological)
Placebo IV
Placebo Comparator
Placebo Administered Intravenously
干预措施: LBR-101 IV (Biological)
Placebo SC
Placebo Comparator
Placebo Administered Subcutaneously
干预措施: LBR-101 SC (Biological)
LBR-101 Dose 2 IV
Experimental
LBR-101 Dose 2 Administered Intravenously
干预措施: LBR-101 IV (Biological)
LBR-101 Dose 2 SC
Experimental
LBR-101 Dose 2 Administered Subcutaneously
干预措施: LBR-101 SC (Biological)
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 (1)
Loading locations...
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