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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ABBV-141; Drug: Placebo for ABBV-141

Study type: Interventional

Funder types: Industry

Identifiers

NCT06148181

M24-693

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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41 participants in 8 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: ABBV-141

Drug: ABBV-141

Part 1, Placebo for ABBV-141 (IV)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo for ABBV-141

Drug: Placebo for ABBV-141

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

Experimental group

Description:

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

Treatment:

Drug: ABBV-141

Drug: ABBV-141

Part 1, Placebo for ABBV-141 (SC)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo for ABBV-141

Drug: Placebo for ABBV-141

Part 2, ABBV-141 (IV)

Experimental group

Description:

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

Treatment:

Drug: ABBV-141

Drug: ABBV-141

Part 2, Placebo for ABBV-141 (IV)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo for ABBV-141

Drug: Placebo for ABBV-141

Part 2, ABBV-141 (SC)

Experimental group

Description:

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

Treatment:

Drug: ABBV-141

Drug: ABBV-141

Part 2, Placebo for ABBV-141 (SC)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo for ABBV-141

Drug: Placebo for ABBV-141