A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) of ABBV-903
研究概览
简要总结
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of ABBV-903 or placebo in healthy adult Japanese and Han Chinese subjects.
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
- 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 Japanese or Han Chinese male or female; age is between 18 and 65 years, inclusive at the time of screening.
- •Han Chinese subject must be first-generation Han Chinese of full Chinese parentage residing outside of China. Subjects must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- •Japanese subject must be first- or second generation Japanese of full Japanese parentage. First-generation subjects will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All subjects must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
- •Body Mass Index (BMI) is >= 18.0 to <= 30.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
排除标准
- •History of any clinically significant illness/infection/major febrile illness, hospitalization, as determined by the investigator, or any surgical procedure within 30 days prior to the first dose of study drug.
- •Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma orlocalized carcinoma in situ of the cervix.
研究组 & 干预措施
Part 1: Han-Chinese Participants ABBV-903
Han-Chinese participants will receive a single dose of ABBV-903.
干预措施: ABBV-903 (Drug)
Part 1: Japanese Participants ABBV-903
Japanese participants will receive a single dose of ABBV-903.
干预措施: ABBV-903 (Drug)
Part 1: Placebo
Participants will receive a single dose of Placebo for ABBV-903.
干预措施: Placebo for ABBV-903 (Drug)
Part 2: Japanese Participants ABBV-903
Japanese participants will receive ABBV-903 daily for 10 days.
干预措施: ABBV-903 (Drug)
Part 2: Japanese Participants Placebo
Japanese participants will receive placebo daily for 10 days.
干预措施: Placebo for ABBV-903 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of ABBV-903
时间窗: Up to Day 4
Cmax of ABBV-903 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
时间窗: Up to Day 4
Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
Number of Participants with Adverse Events (AEs)
时间窗: Baseline to Day 34
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903
时间窗: Up to Day 4
AUC0-t of ABBV-903 will be assessed.
AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903
时间窗: Up to Day 4
AUC0-inf of ABBV-903 will be assessed.
Time to Cmax (Tmax) of ABBV-903
时间窗: Up to Day 4
Tmax of ABBV-903 will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903
时间窗: Up to Day 4
Apparent terminal phase elimination rate constant (β) of ABBV-903 will be assessed.
次要结局
未报告次要终点