A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by the investigator
- •Normal or clinically acceptable electrocardiogram (ECG)
- •Female subjects must be of documented non-reproductive potential
- •Subjects must be current for all vaccinations
- •Other inclusion criteria may apply
排除标准
- •Current or chronic history of liver disease
- •History of active infections
- •History of significant respiratory disorder
- •Evidence of renal disease
- •Other exclusion criteria may apply
结局指标
主要结局
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
时间窗: Day 1 to Day 105
TEAEs were adverse events with an onset after the administration of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria: * Results in death (fatal) * Immediately life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event
Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations
时间窗: Baseline to Day 105
Physical examinations were performed by the investigator, designated physician, or nurse practitioner. A complete physical examination included, at a minimum, assessment of cardiovascular, respiratory, gastrointestinal and neurological systems. A brief physical examination included assessment of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).
Number of Participants Who Experienced a Clinically Significant Change in Vital Signs
时间窗: Baseline to Day 105
Any changes in blood pressure, body temperature, heart rate, and pulse rate that were deemed as clinically significant by the Investigator were reported.
Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests
时间窗: Baseline to Day 105
Laboratory safety tests included chemistry, hematology, and urinalysis parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)
时间窗: Baseline to Day 105
Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported.
次要结局
- Maximum Observed Concentration (Cmax) of AMG 570(Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105)
- Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result(Baseline to Day 105)
- Time to Reach Maximum Observed Concentration (Tmax) of AMG 570(Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105)
- Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570(Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105)
- Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570(Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105)
- Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)(Baseline to Day 8; Day 29; Day 57 and Day 105)
- Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells(Day 8; Day 29; Day 57; and Day 105)
- Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts(Baseline to Day 8; Day 29; Day 57 and Day 105)