A First-In-Human Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-722 Following Single and Multiple Ascending Doses in Healthy Adult Subjects and Single Doses in Healthy Adult Asian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 3
- 主要终点
- Number of Participants with Adverse Events Reported During Safety Evaluations
研究概览
简要总结
This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Laboratory values meet the criteria specified in the protocol.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
- •Part 2 only: Healthy Han Chinese and Japanese individuals between 18 and 65 years of age, inclusive at the time of Screening.
- •Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- •First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent.
- •Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent. OR
- •Participant must be first- or second-generation Japanese of full Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
- •First-generation participants will have been born in Japan to two parents and four grandparents, who were also born in Japan, and are of full Japanese descent.
- •Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.
排除标准
- •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 drug.
- •Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.
- •Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
研究组 & 干预措施
Part 1: Group 4
Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.
干预措施: Placebo (Drug)
Part 1: Group 5
Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.
干预措施: Placebo (Drug)
Part 1: Group 1
Participants will receive a single dose of either ABBV-722 Dose A or placebo.
干预措施: Placebo (Drug)
Part 1: Group 2
Participants will receive a single dose of either ABBV-722 Dose B or placebo.
干预措施: Placebo (Drug)
Part 1: Group 3
Participants will receive a single dose of either ABBV-722 Dose C or placebo.
干预措施: Placebo (Drug)
Part 3: Group 8
Participants will receive either ABBV-722 Dose E or placebo for 14 days.
干预措施: Placebo (Drug)
Part 3: Group 10
Participants will receive either ABBV-722 Dose A or placebo for 14 days.
干预措施: Placebo (Drug)
Part 3: Group 9
Participants will receive either ABBV-722 Dose F or placebo for 14 days.
干预措施: ABBV-722 (Drug)
Part 3: Group 9
Participants will receive either ABBV-722 Dose F or placebo for 14 days.
干预措施: Placebo (Drug)
Part 3: Group 10
Participants will receive either ABBV-722 Dose A or placebo for 14 days.
干预措施: ABBV-722 (Drug)
Part 2: Group 7
Participants who are Japanese will receive a single dose of ABBV-722 Dose D.
干预措施: ABBV-722 (Drug)
Part 3: Group 11
Participants will receive either ABBV-722 Dose G or placebo for 14 days.
干预措施: Placebo (Drug)
Part 3: Group 12
Participants will receive either ABBV-722 Dose TBD or placebo for 14 days.
干预措施: Placebo (Drug)
Part 3: Group 11
Participants will receive either ABBV-722 Dose G or placebo for 14 days.
干预措施: ABBV-722 (Drug)
Part 3: Group 12
Participants will receive either ABBV-722 Dose TBD or placebo for 14 days.
干预措施: ABBV-722 (Drug)
Part 1: Group 1
Participants will receive a single dose of either ABBV-722 Dose A or placebo.
干预措施: ABBV-722 (Drug)
Part 1: Group 2
Participants will receive a single dose of either ABBV-722 Dose B or placebo.
干预措施: ABBV-722 (Drug)
Part 1: Group 3
Participants will receive a single dose of either ABBV-722 Dose C or placebo.
干预措施: ABBV-722 (Drug)
Part 1: Group 4
Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.
干预措施: ABBV-722 (Drug)
Part 1: Group 5
Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.
干预措施: ABBV-722 (Drug)
Part 2: Group 6
Participants who are Han Chinese will receive a single dose of ABBV-722 Dose D.
干预措施: ABBV-722 (Drug)
Part 3: Group 8
Participants will receive either ABBV-722 Dose E or placebo for 14 days.
干预措施: ABBV-722 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events Reported During Safety Evaluations
时间窗: Up to Day 44
Safety evaluations will include AE monitoring, vital sign measurements (including orthostatic blood pressure and pulse rate), ECG variables, and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration. Clinically significant abnormal changes in physical examination findings will be reported as AEs.
Maximum Plasma Concentration (Cmax) of ABBV-722
时间窗: Up to Day 21
Cmax of ABBV-722.
Time to Cmax (Tmax) of ABBV-722
时间窗: Up to Day 21
Tmax of ABBV-722.
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722
时间窗: Up to Day 8
AUCt of ABBV-722.
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722
时间窗: Up to Day 8
AUCinf of ABBV-722
For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722
时间窗: Up to Day 21
Ctrough of ABBV-722.
For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722
时间窗: Up to Day 21
AUC from AUCtau following the first and last doses of ABBV-722.
Terminal Phase Elimination Rate Constant (Beta) of ABBV-722
时间窗: Up to Day 21
Beta of ABBV-722.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722
时间窗: Up to Day 21
t1/2 of ABBV-722.
Dose Normalized Cmax
时间窗: Up to Day 21
Dose normalized Cmax.
Dose Normalized AUCs
时间窗: Up to Day 21
Dose normalized AUCs.
次要结局
未报告次要终点