A First in Human, Single Ascending Dose Study of ABBV-1451 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Healthy Subjects and in Japanese and Han Chinese Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Terminal Phase Elimination Rate Constant (β) of ABBV-1451
研究概览
简要总结
The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-1451 after single ascending doses in healthy adult volunteers.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
- •Applies to Part 2 only:
- •For Japanese participants:
- •-- Participant must be first or second-generation Japanese of full Japanese parentage, residing outside of Japan. 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. Participants must be in general good health.
- •For Han Chinese participants:
- •Participant must be first or second-generation Han Chinese of full Chinese parentage, residing outside of China. First generation participants will have been born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must be in general good health.
排除标准
- •History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of any clinically significant sensitivity or allergy to any medication or food.
- •History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
研究组 & 干预措施
Part 2: Group 8
Han Chinese participants will receive a single dose of ABBV-1451 Dose C or placebo.
干预措施: Placebo (Other)
Part 1: Group 6
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose TBD or placebo.
干预措施: Placebo (Other)
Part 2: Group 8
Han Chinese participants will receive a single dose of ABBV-1451 Dose C or placebo.
干预措施: ABBV-1451 (Drug)
Part 1: Group 1
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo.
干预措施: ABBV-1451 (Drug)
Part 1: Group 1
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo.
干预措施: Placebo (Other)
Part 1: Group 2
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose B or placebo.
干预措施: ABBV-1451 (Drug)
Part 1: Group 2
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose B or placebo.
干预措施: Placebo (Other)
Part 1: Group 3
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo.
干预措施: ABBV-1451 (Drug)
Part 1: Group 3
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo.
干预措施: Placebo (Other)
Part 1: Group 4
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo.
干预措施: ABBV-1451 (Drug)
Part 1: Group 4
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo.
干预措施: Placebo (Other)
Part 1: Group 5
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo.
干预措施: Placebo (Other)
Part 1: Group 5
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo.
干预措施: ABBV-1451 (Drug)
Part 1: Group 6
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose TBD or placebo.
干预措施: ABBV-1451 (Drug)
Part 2: Group 7
Japanese participants will receive a single dose of ABBV-1451 Dose C or placebo.
干预措施: ABBV-1451 (Drug)
Part 2: Group 7
Japanese participants will receive a single dose of ABBV-1451 Dose C or placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Terminal Phase Elimination Rate Constant (β) of ABBV-1451
时间窗: Up to Approximately Day 211
β of ABBV-1451.
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately Day 211
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Maximum Observed Plasma Concentration (Cmax) of ABBV-1451
时间窗: Up to Approximately Day 211
Cmax of ABBV-1451.
Time to Cmax (Tmax) of ABBV-1451
时间窗: Up to Approximately Day 211
Tmax of ABBV-1451.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1451
时间窗: Up to Approximately Day 211
t1/2 of ABBV-1451.
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-1451
时间窗: Up to Approximately Day 211
AUCt of ABBV-1451.
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-1451
时间窗: Up to Approximately Day 211
AUCinf of ABBV-1451.
次要结局
未报告次要终点