ABBV-142 for Healthy Subjects
AC
Overseen ByABBVIE CALL CENTER
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: AbbVie
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the ABBV-142 trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Who Is on the Research Team?
AI
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
This clinical trial is for healthy adults. Specific eligibility criteria are not detailed, but typically participants should have no significant medical conditions and be willing to comply with study procedures.Inclusion Criteria
Volunteers in general good health
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.
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.
Exclusion Criteria
I haven't had any serious illnesses, infections, fevers, hospital stays, or surgeries in the last 30 days.
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.
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive single ascending doses of ABBV-142 or placebo
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety, tolerability, and pharmacokinetics of ABBV-142
Up to 120 days
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-142
Trial Overview The trial is testing ABBV-142, a new medication given by subcutaneous injections or intravenous infusions. It's being compared to a placebo to see how the body processes it and if it's safe at effective doses.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Group I: Part 3: Group 9Experimental Treatment2 Interventions
Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.
Group II: Part 3: Group 8Experimental Treatment2 Interventions
Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.
Group III: Part 2: Group 7Experimental Treatment2 Interventions
Participants will receive ABBV-142 Dose C or Placebo on Day 1.
Group IV: Part 2: Group 6Experimental Treatment2 Interventions
Participants will receive ABBV-142 Dose B or Placebo on Day 1.
Group V: Part 1: Group 5 (Optional)Experimental Treatment2 Interventions
Participants will receive ABBV-142 Dose TBD or Placebo on Day 1.
Group VI: Part 1: Group 4Experimental Treatment2 Interventions
Participants will receive ABBV-142 Dose D or Placebo on Day 1.
Group VII: Part 1: Group 3Experimental Treatment2 Interventions
Participants will receive ABBV-142 Dose C or Placebo on Day 1.
Group VIII: Part 1: Group 2Experimental Treatment2 Interventions
Participants will receive ABBV-142 Dose B or Placebo on Day 1.
Group IX: Part 1: Group 1Experimental Treatment2 Interventions
Participants will receive ABBV-142 Dose A or Placebo on Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
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