A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single Doses Subcutaneous Administration of TEV-48125 (Doses up to 900 mg) in Japanese and Caucasian Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Percentage extrapolated AUC (%AUCext)
研究概览
简要总结
This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •The subject is a man or woman, 18 to 55 years of age, inclusive
- •The subject has a body mass index (BMI) ranging from 17.5 to 28.0 kg/m2, inclusive
- •The subjects must be in a good health at screening and check-in
- •Additional inclusion criteria for Japanese subjects:
- •Subject must be a non-naturalized Japanese citizen and hold a Japanese passport
- •Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non naturalized Japanese citizens
- •Subject has been living outside of Japan for no more than 10 years
- •Additional inclusion criteria for Caucasian subjects:
- •The subject has/had 2 Caucasian parents and 4 Caucasian grandparents. Caucasian includes White and Hispanic ethnicities.
- •Additional criteria apply, please contact the investigator for more information
排除标准
- •The subject is a woman who is pregnant or lactating
- •The subject is suffering from, or has a clinically significant history of, 1 or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematologic or psychiatric disorder(s)
- •The subject has a known allergy or sensitivity to injected proteins, including monoclonal antibodies, or any other component of the formulation. In addition, presence of history of allergies requiring acute or chronic treatment
- •Precipitation in another clinical study of a new investigational drug within 30 days (90 days for biologics) before dosing
- •Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
TEV-48125 - 1
Dose Regimen 1
干预措施: TEV-48125 - 1 (Drug)
TEV-48125 - 2
Dose Regimen 2
干预措施: TEV-48125 - 2 (Drug)
TEV-48125 - 3
Dose Regimen 3
干预措施: TEV-48125 - 3 (Drug)
Placebo
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage extrapolated AUC (%AUCext)
时间窗: 33 weeks
Apparent serum terminal elimination rate constant (λz)
时间窗: 33 weeks
Maximum observed plasma drug concentration (Cmax)
时间窗: 33 weeks
Time to maximum observed plasma drug concentration (tmax)
时间窗: 33 weeks
AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t)
时间窗: 33 weeks
AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672)
时间窗: 33 weeks
AUC from time 0 extrapolated to infinity (AUC0-∞)
时间窗: 33 weeks
Apparent total body clearance (CL/F)
时间窗: 33 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
时间窗: 33 weeks
Apparent serum terminal elimination half-life (t½)
时间窗: 33 weeks
次要结局
- Percentage of Participants with Adverse Events(33 weeks)
- Tolerability- Percentage of participants who fail to complete the study(33 weeks)
- Percentage of participants who fail to complete the study due to adverse events(33 Weeks)