ABBV-701 for Healthy Subjects
AC
Overseen ByABBVIE CALL CENTER
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: AbbVie
No Placebo Group
Trial Summary
What is the purpose of this trial?
The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous (SC) ABBV-701 in healthy adult western and Asian participants.
Research Team
AI
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for healthy adults from Western and Asian backgrounds. Specific eligibility criteria are not detailed, but typically participants must meet certain health standards and not have conditions that could interfere with the study.Inclusion Criteria
Body Mass Index (BMI) must be ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters
For 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 consuming a typical Japanese diet. For 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.
My overall health is good based on recent medical exams.
Exclusion Criteria
History of any clinically significant sensitivity or allergy to any medication or food
I don't have any major health issues apart from my cancer.
Treatment Details
Interventions
- ABBV-701 (Monoclonal Antibodies)
Trial OverviewThe study is testing ABBV-701, a new medication given as a subcutaneous injection. Participants will be randomly assigned to receive either ABBV-701 or a placebo to compare effects on safety, how the body processes it, and if it causes an immune response.
Participant Groups
7Treatment groups
Experimental Treatment
Group I: Part 2: Group 7 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose E or placebo.
Group II: Part 2: Group 6 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose E or placebo.
Group III: Part 1: Group 5 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose E or placebo.
Group IV: Part 1: Group 4 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose D or placebo.
Group V: Part 1: Group 3 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose C or placebo.
Group VI: Part 1: Group 2 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose B or placebo.
Group VII: Part 1: Group 1 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose A or placebo.
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