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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT06148181

Run by

AbbVie

People needed

41

Starts

2024-01-29

Expected to finish

2024-12-30

Last updated by the study team

2025-01-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
• Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal.
• 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 four grandparents born in Japan and of Japanese descent.

You may not qualify if…

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease 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 collection site planned as per schedule of activities.
• History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder.
• History of sensitivity to or allergies to adhesives or evidence of fragile or easily damaged skin.
• Evidence of hypertrophic scarring.

Where it is running

• Acpru /Id# 261162 — Grayslake, Illinois, United States

Full record on ClinicalTrials.gov

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