NCT02284607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 HIGH DOSE 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
- 14
- 试验地点
- 1
- 主要终点
- Changes in vital signs during and following MHAA4549A administration
研究概览
简要总结
This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as compared to placebo when administered 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
- Other
- 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
- •Age 18 years and older
- •Body mass index (BMI) between 18 and 32 kg/m2, inclusive
- •Weight 40 - 100 kg
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations
- •Willing to use acceptable contraceptive measures as defined by the protocol
- •Agreeable to, and deemed able to by the investigator, to comply with the requirements of the study, including the follow-up period
- •Willing to abstain from the use of drugs of abuse while enrolled in the study
排除标准
- •History or clinically significant manifestations of disorders
- •History of acute allergic reaction 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
- •Males who have a pregnant female partner
- •Donation of plasma within 7 days prior to study drug administration
- •Donation or loss of whole blood
- •Receipt of blood products within 2 months before initiation of dosing on Day 1
- •History of malignancy within 10 years of screening except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
- •History of severe systemic bacterial, fungal, or parasitic infections associated with more than two hospitalizations per year or more than two courses of intravenous (IV) antibiotics within 1 year
- •Received oral antibiotics within 4 weeks before initiation of dosing on Day 1, or IV antibiotics within 8 weeks before initiation of dosing
- •Hospitalization within 4 weeks before initiation of dosing on Day 1
- •Use of any over the counter or prescription medications/products within 7 days prior to Day 1 and unwilling to abstain from the use of such drugs up until at least the Day 29 study visit, unless deemed acceptable by the investigator and Sponsor
- •Participation in a clinical trial within 4 weeks
- •Received any vaccine within 14 days prior to screening
- •Positive blood test for chronic viral infections
研究组 & 干预措施
MHAA4549A higher dose
Experimental
干预措施: MHAA4549A (Drug)
MHAA4549A lower dose
Experimental
干预措施: MHAA4549A (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in vital signs during and following MHAA4549A administration
时间窗: From baseline to end of study, up to 120 days
Incidence and nature of adverse events (AEs)
时间窗: Until study discontinuation/termination, up to 120 days
Changes in ECG findings during and following MHAA4549A administration
时间窗: From baseline to end of study, up to 120 days
Severity of AEs
时间窗: Until study discontinuation/termination, up to 120 days
次要结局
- Pharmacokinetics (composite outcome measure): parameters derived from the nasal and serum concentration-time profile of MHAA4549A (area under the concentration-time curve [AUC], Cmax, tmax, clearance, Vss, half-life (t1/2), mean residence time)(Up to 120 days)
研究者
研究点 (1)
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