NCT01395485撤回1 期
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescent (12 to <18 Years) and Adult Subjects With Intermittent or Mild to Moderate Persistent Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Amgen
- 主要终点
- Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and/or female subjects 12 to < 18 years of age at the time of randomization
- •Male and/or female subjects between 18 and 50 years of age (inclusive) at the time of randomization
- •Body weight ≥ 36 kg at screening
- •Intermittent or mild to moderate persistent asthma for at least the past 3 months prior to study enrollment (as defined by the 2004 Global Initiative for Asthma [GINA] guidelines.
排除标准
- •Experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room or urgent care facility, or an episode treated with oral corticosteroids) during the 3 months prior to study enrollment.
- •Hospitalized for asthma during the 6 months prior to study enrollment; or ever intubated for the treatment of asthma.
- •Use of oral corticosteroids within 3 months prior to study enrollment.
研究组 & 干预措施
Cohort 2
Experimental
Adolescents - Ages 13 to <17
干预措施: AMG 827 or Placebo (Drug)
Cohort 1
Experimental
Adolescents - Ages 12 to <13
干预措施: AMG 827 or Placebo (Drug)
Cohort 4
Experimental
Adults - Ages 18 to <=50
干预措施: AMG 827 or Placebo (Drug)
Cohort 3
Experimental
Adolescents - Ages 17 to <18
干预措施: AMG 827 or Placebo (Drug)
结局指标
主要结局
Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability
时间窗: Participants will be followed for the duration of the study, an expected average of 5 weeks
次要结局
- Area under the AMG 827 concentration versus time curve (AUC) for times 0 to infinity (AUC 0-inf) and 0 to last sampling time point (AUC 0-tlast), peak plasma concentration (Cmax) and Time to peak plasma concentration (tmax) will be determined for AMG 827(Intermittantly throughout the duration of the study, an expected average of 5 weeks)
- Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adult subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability(Intermittantly throughout the duration of the study, an expected average of 5 weeks)
研究者
相似试验
已完成
1 期
Safety, Tolerability, and Pharcodynamics of AMG 853 in Adolescents With AsthmaAsthmaNCT01137565Amgen23
已完成
3 期
Seasonal Allergic Rhinitis In Pediatric SubjectsRhinitis, Allergic, PerennialNCT00107757GlaxoSmithKline576
已完成
1 期
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly CohortAlzheimer's DiseaseNCT01294540Eisai Inc.73
已完成
1 期
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy SubjectsThrombosisNCT03197779Bristol-Myers Squibb691
已完成
1 期
Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male ParticipantsJapanese Healthy Adult Male ParticipantsNCT03237156Takeda24