A Phase I, Open-label, Randomized, Parallel-arm, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133
研究概览
简要总结
The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian 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
- None
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 male or female participants between 18 and 65 years of age (inclusive) at the time of Screening (Japanese participants must be first-generation Japanese)
- •In good health, determined by no clinically significant findings from medical history, physical examination, ECG, vital signs measurements, and clinical laboratory evaluations
- •Body mass index between 18 and 30 kg/m^2 at the time of Screening
- •Females of nonchildbearing potential
排除标准
- •History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease
- •History or current signs or symptoms of cardiovascular disease
- •History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in
- •History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- •Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening
- •History of alcoholism or drug/chemical abuse within 1 year prior to Check-in
- •Use of tobacco- or nicotine-containing products within 6 months prior to Check-in
- •Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Screening or Check-in
- •Female participants with a positive pregnancy test at Screening or Check-in
- •Female participants lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the end of study (EOS) visit
- •Donation of blood from 3 months prior to Check-in, plasma from 2 weeks prior to Check-in, or platelets from 6 weeks prior to Check-in
- •Unwilling to abide with study restrictions
研究组 & 干预措施
Japanese Participants: AMG 133 Low Dose
Healthy Japanese participants will receive the low dose of AMG 133 as a SC injection on Day 1 of the study.
干预措施: AMG 133 (Drug)
Japanese Participants: AMG 133 Medium Dose
Healthy Japanese participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study.
干预措施: AMG 133 (Drug)
Japanese Participants: AMG 133 High Dose
Healthy Japanese participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study.
干预措施: AMG 133 (Drug)
Caucasian Participants: AMG 133 Medium Dose
Healthy Caucasian participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study.
干预措施: AMG 133 (Drug)
Caucasian Participants: AMG 133 High Dose
Healthy Caucasian participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study.
干预措施: AMG 133 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133
时间窗: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Cmax of Total AMG 133
时间窗: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133
时间窗: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
AUClast of Total AMG 133
时间窗: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133
时间窗: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
AUCinf of Total AMG 133
时间窗: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
次要结局
- Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)(Day 1 to Day 120)
- Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result(Days 1, 15, 29, 57 and 120)