A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants

Last updated: January 22, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo for ABBV-141

ABBV-141

Clinical Study ID

NCT06148181
M24-693
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A condition of general good health, based upon the results of a medical history,physical examination, vital signs, laboratory profile and a 12-leadelectrocardiogram (ECG).

  • Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenthsdecimal.

For Part 2 only:

-Han Chinese ethnicity or Japanese ethnicity based on the following criteria:

  • Han Chinese: First-generation Han Chinese with both parents of Han Chinese descent.

  • Japanese: First- or second-generation Japanese with both parents and all fourgrandparents born in Japan and of Japanese descent.

Exclusion

Exclusion Criteria:

  • History of epilepsy, any clinically significant cardiac, respiratory (except mildasthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatricdisease or disorder, or any uncontrolled medical illness.

  • History of any clinically significant sensitivity or allergy to any medication,topical creams, or food.

Additionally for Part 1, only:

  • Presence of foreign bodies, local irritation or infections, active skin diseases,tattoos, and/or scars on the thighs which may preclude the skin biopsy collectionsite planned as per schedule of activities.

  • History of bruising easily, bleeding disorders, thrombocytopenia, orhypo-coagulation disorder.

  • History of sensitivity to or allergies to adhesives or evidence of fragile or easilydamaged skin.

  • Evidence of hypertrophic scarring.

Study Design

Total Participants: 41
Treatment Group(s): 2
Primary Treatment: Placebo for ABBV-141
Phase: 1
Study Start date:
January 29, 2024
Estimated Completion Date:
December 30, 2024

Connect with a study center

  • Acpru /Id# 261162

    Grayslake, Illinois 60030
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.