Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 334 in Healthy Subjects and in Migraine Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy adults and migraine patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 male and female subjects, as well as male or female subjects with migraines between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician;
排除标准
- •History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
研究组 & 干预措施
Erenumab
Healthy participants and participants with migraine received subcutaneous doses of erenumab on days 1, 29 and 57.
干预措施: Erenumab (Drug)
Placebo
Healthy participants and participants with migraine received subcutaneous doses of placebo on days 1, 29 and 57.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From first dose of study drug until a maximum of 168 days after last dose (225 days)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life-threatening (places the subject at immediate risk of death) * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: From first dose of study drug until a maximum of 168 days after last dose (225 days)
The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.
Number of Participants Who Developed Anti-erenumab Antibodies
时间窗: From first dose of study drug until a maximum of 168 days after last dose (225 days)
Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.
次要结局
- Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)(Day 57 (assessed from predose to day 225)))
- Maximum Observed Serum Concentration (Cmax) of Erenumab(Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225))
- Time to Maximum Observed Concentration (Tmax) of Erenumab(Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225))
- Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)(Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225))
- Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow(Baseline, Days 8, 57, 85, 113, 169 and 197)