A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses of ABBV-142 in Healthy Adult Subjects and Single Doses of ABBV-142 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
- 73
- 试验地点
- 1
- 主要终点
- Time to Cmax (Tmax) of ABBV-142
研究概览
简要总结
This study is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted efficacious exposures can be safely achieved in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers in general good health.
- •Part 3, ONLY:
- •HAN CHINESE Participants:
- •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.
- •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.
- •JAPANESE Participants:
- •Participant must be first- or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health.
- •First-generation participants will have been born in Japan to two parents and four grandparents 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.
- •Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
- •History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
研究组 & 干预措施
Part 3: Group 9
Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.
干预措施: ABBV-142 (Drug)
Part 3: Group 8
Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.
干预措施: Placebo (Drug)
Part 1: Group 1
Participants will receive ABBV-142 Dose A or Placebo on Day 1.
干预措施: ABBV-142 (Drug)
Part 2: Group 7
Participants will receive ABBV-142 Dose C or Placebo on Day 1.
干预措施: Placebo (Drug)
Part 1: Group 1
Participants will receive ABBV-142 Dose A or Placebo on Day 1.
干预措施: Placebo (Drug)
Part 1: Group 2
Participants will receive ABBV-142 Dose B or Placebo on Day 1.
干预措施: ABBV-142 (Drug)
Part 1: Group 3
Participants will receive ABBV-142 Dose C or Placebo on Day 1.
干预措施: Placebo (Drug)
Part 1: Group 4
Participants will receive ABBV-142 Dose D or Placebo on Day 1.
干预措施: ABBV-142 (Drug)
Part 1: Group 4
Participants will receive ABBV-142 Dose D or Placebo on Day 1.
干预措施: Placebo (Drug)
Part 1: Group 5 (Optional)
Participants will receive ABBV-142 Dose TBD or Placebo on Day 1.
干预措施: ABBV-142 (Drug)
Part 1: Group 5 (Optional)
Participants will receive ABBV-142 Dose TBD or Placebo on Day 1.
干预措施: Placebo (Drug)
Part 2: Group 6
Participants will receive ABBV-142 Dose B or Placebo on Day 1.
干预措施: ABBV-142 (Drug)
Part 2: Group 6
Participants will receive ABBV-142 Dose B or Placebo on Day 1.
干预措施: Placebo (Drug)
Part 1: Group 2
Participants will receive ABBV-142 Dose B or Placebo on Day 1.
干预措施: Placebo (Drug)
Part 1: Group 3
Participants will receive ABBV-142 Dose C or Placebo on Day 1.
干预措施: ABBV-142 (Drug)
Part 2: Group 7
Participants will receive ABBV-142 Dose C or Placebo on Day 1.
干预措施: ABBV-142 (Drug)
Part 3: Group 8
Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.
干预措施: ABBV-142 (Drug)
Part 3: Group 9
Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Cmax (Tmax) of ABBV-142
时间窗: Up to Day 120
Tmax of ABBV-142 will be assessed.
Area Under the Serum Concentration-time Curve (AUC) of ABBV-142 from Time 0 to the Time of Last Measurable Concentration (AUCt)
时间窗: Up to Day 120
AUCt of ABBV-142 will be determined.
AUC of ABBV-142 from Time 0 to Infinity (AUCinf)
时间窗: Up to Day 120
AUCinf of ABBV-142 will be assessed.
Terminal Phase Elimination Rate Constant (β) of ABBV-142
时间窗: Up to Day 120
Terminal phase elimination rate constant (β) of ABBV-142 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-142
时间窗: Up to Day 120
Terminal phase elimination half-life (t1/2) of ABBV-142 will be assessed.
Dose Normalized Cmax of ABBV-142
时间窗: Up to Day 120
Dose normalized Cmax of ABBV-142 will be assessed.
Dose Normalized AUC of ABBV-142
时间窗: Up to Day 120
Dose normalized AUC of ABBV-142 will be assessed.
Number of Participants with Adverse Events (AEs)
时间窗: Up to Day 120
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.
Maximum Observed Serum Concentration (Cmax) of ABBV-142
时间窗: Up to Day 120
Cmax of ABBV-142 will be assessed.
次要结局
未报告次要终点