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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1, ABBV-141 (Intravenous [IV])

Western participants will receive a single IV dose of ABBV-141.

Group Type EXPERIMENTAL

ABBV-141

Intervention Type DRUG

Infusion; intravenous (IV)

Part 1, Placebo for ABBV-141 (IV)

Western participants will receive a single IV dose of placebo for ABBV-141.

Group Type PLACEBO_COMPARATOR

Placebo for ABBV-141

Intervention Type DRUG

Infusion; IV

Part 1, ABBV-141 (subcutaneous [SC])

Western participants will receive a single SC dose of ABBV-141.

Group Type EXPERIMENTAL

ABBV-141

Intervention Type DRUG

Injection; subcutaneous (SC)

Part 1, Placebo for ABBV-141 (SC)

Western participants will receive a single SC dose of placebo for ABBV-141.

Group Type PLACEBO_COMPARATOR

Placebo for ABBV-141

Intervention Type DRUG

Injection; SC

Part 2, ABBV-141 (IV)

Asian participants will receive a single IV dose of ABBV-141.

Group Type EXPERIMENTAL

ABBV-141

Intervention Type DRUG

Infusion; intravenous (IV)

Part 2, Placebo for ABBV-141 (IV)

Asian participants will receive a single IV dose of placebo for ABBV-141.

Group Type PLACEBO_COMPARATOR

Placebo for ABBV-141

Intervention Type DRUG

Infusion; IV

Part 2, ABBV-141 (SC)

Asian participants will receive a single SC dose of ABBV-141.

Group Type EXPERIMENTAL

ABBV-141

Intervention Type DRUG

Injection; subcutaneous (SC)

Part 2, Placebo for ABBV-141 (SC)

Asian participants will receive a single SC dose of placebo for ABBV-141.

Group Type PLACEBO_COMPARATOR

Placebo for ABBV-141

Intervention Type DRUG

Injection; SC

Interventions

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ABBV-141

Infusion; intravenous (IV)

Intervention Type DRUG

Placebo for ABBV-141

Infusion; IV

Intervention Type DRUG

ABBV-141

Injection; subcutaneous (SC)

Intervention Type DRUG

Placebo for ABBV-141

Injection; SC

Intervention Type DRUG

Eligibility Criteria

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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-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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes