41 Participants Needed

ABBV-141 for Healthy Adults

AC
Overseen ByABBVIE CALL CENTER
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: AbbVie

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.

Research Team

AI

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for healthy adults who are either Western or of specific Asian descent (Han Chinese or Japanese). Participants must be in good health as determined by medical exams, have a BMI between 18.0 and 32.0, and for Asians, they need to have parents/grandparents of the same descent.

Inclusion Criteria

My Body Mass Index (BMI) is between 18.0 and 32.0.
You are the first generation with both parents of Han Chinese descent.
You are of Japanese descent with all your parents and grandparents born in Japan.
See 2 more

Exclusion Criteria

History of any clinically significant sensitivity or allergy to any medication, topical creams, or food.
I have a history of easy bruising, bleeding disorders, or issues with blood clotting.
I have thick, raised scars.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of ABBV-141 or placebo via IV or SC administration

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, pharmacokinetics, and immunogenicity after treatment

Up to 85 days
Multiple visits (in-person)

Treatment Details

Interventions

  • ABBV-141
Trial Overview The study is testing ABBV-141, a new drug. It's given in different amounts to see how it's tolerated and how it moves through the body compared to a placebo (a substance with no active drug).
Participant Groups
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2, ABBV-141 (SC)Experimental Treatment1 Intervention
Asian participants will receive a single SC dose of ABBV-141.
Group II: Part 2, ABBV-141 (IV)Experimental Treatment1 Intervention
Asian participants will receive a single IV dose of ABBV-141.
Group III: Part 1, ABBV-141 (subcutaneous [SC])Experimental Treatment1 Intervention
Western participants will receive a single SC dose of ABBV-141.
Group IV: Part 1, ABBV-141 (Intravenous [IV])Experimental Treatment1 Intervention
Western participants will receive a single IV dose of ABBV-141.
Group V: Part 2, Placebo for ABBV-141 (SC)Placebo Group1 Intervention
Asian participants will receive a single SC dose of placebo for ABBV-141.
Group VI: Part 1, Placebo for ABBV-141 (IV)Placebo Group1 Intervention
Western participants will receive a single IV dose of placebo for ABBV-141.
Group VII: Part 1, Placebo for ABBV-141 (SC)Placebo Group1 Intervention
Western participants will receive a single SC dose of placebo for ABBV-141.
Group VIII: Part 2, Placebo for ABBV-141 (IV)Placebo Group1 Intervention
Asian participants will receive a single IV dose of placebo for ABBV-141.

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 profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

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