A Phase I, Double Blind, Placebo-controlled, Randomized, Parallel, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 Administered Subcutaneously in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592
研究概览
简要总结
The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants.
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
- Double (Participant, 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
- •Participant must be first generation Japanese (4 grandparents, biologic parents, and subject born in Japan and of Japanese heritage)
- •Male and female participants must be ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 25.0 kg/m^2 at the time of screening
排除标准
- •Participant with history of prior malignancy within the last 5 years except malignancy (in situ) fully excised or treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician, non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
- •Participants with a known history of autoimmune disease
- •Participants who have donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP
- •Participants with any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1
- •Positive for Hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
- •Participant has positive test results for Human Immunodeficiency Virus (HIV)
- •Participant has a positive test for tuberculosis during screening defined as either a positive purified derivative (PPD) (>= 5 mm of induration at 48 to 72 hours after test is placed) OR a positive QuantiFERON test
研究组 & 干预措施
Arm 1: AMG 592 Dose 1
Participants will receive AMG 592 dose 1 subcutaneously
干预措施: AMG 592 (Drug)
Arm 2: AMG 592 Dose 2
Participants will receive AMG 592 dose 2 subcutaneously
干预措施: AMG 592 (Drug)
Arm 3: Placebo
Participants will receive placebo subcutaneously
干预措施: Placebo (Other)
结局指标
主要结局
Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592
时间窗: Up to Day 43
Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)
时间窗: Up to Day 43
Maximum Observed Serum Concentration (Cmax) of AMG 592
时间窗: Up to Day 43
Time of Maximum Observed Concentration (tmax) of AMG 592
时间窗: Up to Day 43
次要结局
- Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)(Day 1 to Day 43)
- Number of Participants who Experience Anti-AMG 592 Antibodies Formation(Up to Day 43)