Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 主要终点
- Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments.
研究概览
简要总结
The primary purpose of this study is to determine the safety, tolerability and pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate controlled asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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 volunteers:
- •A condition of good health based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
- •BMI 18 to 29, inclusive.
- •Mild asthma patients:
- •Diagnosis of well-controlled, mild to moderate asthma by GINA guidelines for > or = to 6 months
- •A condition of good health (than mild to moderate asthma) based upon the results of medical history, physical examination, vital signs laboratory profile and EDG.
- •BMI 18 to 34, inclusive.
排除标准
- •Asthma exacerbation within 8 weeks of Study Day
- •Clinically significant allergic reaction to any drug, biologic, food, or vaccine.
- •History of allergic reaction or significant sensitivity to constituents of study drug.
- •Receipt of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
- •Subject is a smoker or has a history of smoking within the 6-month period preceding study drug administration.
- •Current enrollment in another clinical study.
研究组 & 干预措施
IV ABT-308 in asthmatics
ABT-308 single escalating doses in mild to moderate asthmatics
干预措施: ABT-308 (Drug)
IV ABT-308 in asthmatics
ABT-308 single escalating doses in mild to moderate asthmatics
干预措施: Placebo (Drug)
SC ABT-308 in asthmatics
ABT-308 multiple SQ doses in mild to moderate asthmatics
干预措施: ABT-308 (Drug)
SC ABT-308 in asthmatics
ABT-308 multiple SQ doses in mild to moderate asthmatics
干预措施: Placebo (Drug)
IV ABT-308 in healthy volunteers
ABT-308 single escalating IV doses in healthy volunteers
干预措施: ABT-308 (Drug)
IV ABT-308 in healthy volunteers
ABT-308 single escalating IV doses in healthy volunteers
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments.
时间窗: 12 weeks after last dose
次要结局
- Pharmacokinetics will be determined by measuring serum concentration of ABT-308.(12 weeks after last dose)
- Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies.(12 weeks after last dose)