NCT01540760已完成1 期
A Phase Ib, Single-Center, Randomized, Placebo-Controlled, Double-Blind Multiple Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers
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
- 23
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15 and 29.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females, 18 - 55 years of age
- •Subjects in good health as determined by screening medical history, physical examination, vital signs, 12-lead ECG and laboratory tests
- •Body weight between 45 kg and 110 kg
- •Female subjects must be willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug
排除标准
- •Pregnant or lactating women
- •Positive for hepatitis B, hepatitis C or HIV infection
- •History of significant chronic or recurrent infections
- •History of clinically significant drug allergy and/or a known hypersensitivity to protein therapeutics or formulation components or a related drug
- •History of alcohol or drug abuse within 12 months prior to Day 1, or evidence of such abuse
- •Subjects who have previously received the study drug
- •Participation in a clinical trial within 4 weeks prior to Day 1 or use of any experimental or biologic therapy within 12 weeks prior to Day 1 or within 5 half-lives of the product, whichever is greater
研究组 & 干预措施
MCAF5352A
Experimental
干预措施: MCAF5352A (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: approximately 5 months
次要结局
- Pharmacokinetics: Area under the concentration-time curve(Pre-dose and 5 time points up to 14 days post-dose)
- Immunogenicity: Serum MCAF5252A antibodies(Days 1, 29, 50, 78, 106 and 134)
研究者
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