An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-552 in Healthy Adult Japanese and Han Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552
研究概览
简要总结
This study will assess how safe ABBV-552 is and how ABBV-552 moves through the body of adult healthy Japanese and Han Chinese participants. Adverse Events will be assessed.
ABBV-552 is an investigational drug being developed for potential treatment of Alzheimer's disease (AD). Approximately 18 adult healthy Japanese and Han Chinese volunteers will be enrolled in 2 sites in the United States.
Japanese participants assigned to Arm 1 will receive ascending doses of ABBV-552 oral capsules once every week for 3 weeks. Han Chinese participants assigned to Arm 2 will receive oral ABBV-552 capsules on Day 1. All participants will be followed for 30 days after their last dose.
Participants will be confined for 22 days or 8 days depending on the Arm they are assigned to. Adverse Events and blood tests will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Japanese participants must be first- or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
- •Han Chinese participants must be first-generation Han Chinese of full Chinese parentage residing outside of China for less than 5 years. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
排除标准
- •Has no other clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive ABBV-552.
研究组 & 干预措施
Arm 1: Healthy Japanese Participants
Participants will receive ABBV-552 once a week for 21 Days.
干预措施: ABBV-552 (Drug)
Arm 2: Healthy Han Chinese Participants
Participants will receive ABBV-552 once a week for 7 Days.
干预措施: ABBV-552 (Drug)
结局指标
主要结局
AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552
时间窗: Up to approximately 21 days
AUCinf of ABBV-552.
Maximum Observed Plasma Concentration (Cmax) of ABBV-552
时间窗: Up to approximately 21 days
Maximum observed plasma concentration (Cmax) of ABBV-552.
Number of Participants With Adverse Events (AE)
时间窗: Up to approximately 45 days
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Terminal Phase Elimination Rate Constant (λz) of ABBV-552
时间窗: Up to approximately 21 days
Terminal phase elimination rate constant (λz) of ABBV-552.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-552
时间窗: Up to approximately 21 days
Terminal phase elimination half-life (t1/2) of ABBV-552.
Time to Cmax (Tmax) of ABBV-552
时间窗: Up to approximately 21 days
The time to Cmax (Tmax) of ABBV-552.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUCt) of ABBV-552
时间窗: Up to approximately 21 days
AUCt of ABBV-552.
Apparent Volume of Distribution (Vz/F) of ABBV-552
时间窗: Up to approximately 21 days
Apparent volume of distribution (Vz/F) of ABBV-552.
Dose-Normalized Cmax of ABBV-552 (Arm 1)
时间窗: Up to approximately 21 days
Dose-normalized Cmax of ABBV-552.
Apparent Oral Clearance (CL/F) of ABBV-552
时间窗: Up to approximately 21 days
Apparent oral clearance (CL/F) of ABBV-552.
AUC of ABBV-552 (Arm 1)
时间窗: Up to approximately 21 days
AUC of ABBV-552.
次要结局
未报告次要终点