NCT01877785已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAA4549A 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
- 21
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This randomized, double-blind, placebo-controlled, single-ascending dose study will assess the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching placebo.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Body mass index (BMI) between 18 and 32 kg/m2, inclusive
- •Weight 40 to 100 kg
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- •Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor
- •Volunteers agree to use acceptable contraceptive measures
排除标准
- •History or clinically significant manifestations of disorders
- •History of anaphylaxis, hypersensitivity or drug allergies
- •History or presence of an abnormal ECG
- •History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
- •History of significant drug abuse within 1 year prior to screening
- •Current tobacco smokers
- •Positive drug screen at screening or at check-in
- •Positive pregnancy test result at screening or Day -1 or breast feeding during the study
研究组 & 干预措施
MHAA4549A Arm
Experimental
干预措施: MHAA4549A (Drug)
Placebo Arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 120 days
次要结局
- Incidence of anti-therapeutic antibodies(120 days)
- Pharmacokinetics: Serum concentration-time profile of MHAA4549A(Pre-dose on day 1 to day 120 post-dose)
研究者
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