A Study to Assess the Adverse Events and How Subcutaneous (SC) Injections and Intravenous (IV) Infusions of ABBV-142 Move Through the Body of Healthy Adult Participants
- Registration Number
- NCT06774313
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 74
All Parts:
• 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 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
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 and maintain a typical Japanese lifestyle, including diet.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Group 1 Placebo Participants will receive ABBV-142 Dose A or Placebo on Day 1. Part 1: Group 2 Placebo Participants will receive ABBV-142 Dose B or Placebo on Day 1. Part 1: Group 3 Placebo Participants will receive ABBV-142 Dose C or Placebo on Day 1. Part 1: Group 4 Placebo Participants will receive ABBV-142 Dose D or Placebo on Day 1. Part 1: Group 5 (Optional) Placebo Participants will receive ABBV-142 Dose TBD or Placebo on Day 1. Part 2: Group 6 Placebo Participants will receive ABBV-142 Dose B or Placebo on Day 1. Part 2: Group 7 Placebo Participants will receive ABBV-142 Dose C or Placebo on Day 1. Part 3: Group 8 Placebo Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1. Part 3: Group 9 ABBV-142 Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1. Part 3: Group 9 Placebo Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1. Part 1: Group 4 ABBV-142 Participants will receive ABBV-142 Dose D or Placebo on Day 1. Part 1: Group 5 (Optional) ABBV-142 Participants will receive ABBV-142 Dose TBD or Placebo on Day 1. Part 2: Group 6 ABBV-142 Participants will receive ABBV-142 Dose B or Placebo on Day 1. Part 2: Group 7 ABBV-142 Participants will receive ABBV-142 Dose C or Placebo on Day 1. Part 3: Group 8 ABBV-142 Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1. Part 1: Group 1 ABBV-142 Participants will receive ABBV-142 Dose A or Placebo on Day 1. Part 1: Group 2 ABBV-142 Participants will receive ABBV-142 Dose B or Placebo on Day 1. Part 1: Group 3 ABBV-142 Participants will receive ABBV-142 Dose C or Placebo on Day 1.
- Primary Outcome Measures
Name Time Method Time to Cmax (Tmax) of ABBV-142 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) Up to Day 120 AUCt of ABBV-142 will be determined.
AUC of ABBV-142 from Time 0 to Infinity (AUCinf) Up to Day 120 AUCinf of ABBV-142 will be assessed.
Terminal Phase Elimination Rate Constant (β) of ABBV-142 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 Up to Day 120 Terminal phase elimination half-life (t1/2) of ABBV-142 will be assessed.
Dose Normalized Cmax of ABBV-142 Up to Day 120 Dose normalized Cmax of ABBV-142 will be assessed.
Dose Normalized AUC of ABBV-142 Up to Day 120 Dose normalized AUC of ABBV-142 will be assessed.
Number of Participants with Adverse Events (AEs) 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 Up to Day 120 Cmax of ABBV-142 will be assessed.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Acpru /Id# 271899
🇺🇸Grayslake, Illinois, United States