NCT01847989已完成1 期
A Randomized, Placebo-controlled Single-dose, Double-blind Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in 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
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal platelet count and clotting parameters
- •Adequate renal and hepatic function
- •If female and of child-bearing potential, negative serum pregnancy test within 21 days of enrollment and a negative urine pregnancy test on admission to the clinical research unit
- •If a sexually active male or a sexually active female of child-bearing potential,agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
- •Negative drug and alcohol screens
排除标准
- •Known antibodies or hypersensitivity to FXIII
- •Known bleeding or hematologic disorder
- •Known allergy to yeast
- •Receipt of blood products within 30 days of screening
- •Donation of blood within 30 days prior to enrollment
- •Any surgical procedure in the 30 days prior to enrollment
- •Previous history of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
- •Receipt of treatment with any experimental agent within 30 days of study enrollment
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
rFXIII
Experimental
干预措施: catridecacog (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Days 0-28
次要结局
- Incidence of clinically significant changes from baseline in physical examination or laboratory measurements(Days 0-28)
- Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)(Days 0-28)
- Incidence of yeast antibodies(Days 0-28)
研究者
研究点 (1)
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