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

A Randomized, Double-blind, Placebo-controlled, Phase 1a Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses of ABBV-141 in Healthy Adult Western and Asian Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ABBV-141; Drug: ABBV-141; Drug: Placebo for ABBV-141; Drug: Placebo for ABBV-141

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 261162

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1, ABBV-141 (Intravenous [IV]); Western participants will receive a single IV dose of ABBV-141.	Drug: ABBV-141; Infusion; intravenous (IV); Drug: ABBV-141; Injection; subcutaneous (SC)
Placebo Comparator: Part 1, Placebo for ABBV-141 (IV); Western participants will receive a single IV dose of placebo for ABBV-141.	Drug: Placebo for ABBV-141; Infusion; IV; Drug: Placebo for ABBV-141; Injection; SC
Experimental: Part 1, ABBV-141 (subcutaneous [SC]); Western participants will receive a single SC dose of ABBV-141.	Drug: ABBV-141; Infusion; intravenous (IV); Drug: ABBV-141; Injection; subcutaneous (SC)
Placebo Comparator: Part 1, Placebo for ABBV-141 (SC); Western participants will receive a single SC dose of placebo for ABBV-141.	Drug: Placebo for ABBV-141; Infusion; IV; Drug: Placebo for ABBV-141; Injection; SC
Experimental: Part 2, ABBV-141 (IV); Asian participants will receive a single IV dose of ABBV-141.	Drug: ABBV-141; Infusion; intravenous (IV); Drug: ABBV-141; Injection; subcutaneous (SC)
Placebo Comparator: Part 2, Placebo for ABBV-141 (IV); Asian participants will receive a single IV dose of placebo for ABBV-141.	Drug: Placebo for ABBV-141; Infusion; IV; Drug: Placebo for ABBV-141; Injection; SC
Experimental: Part 2, ABBV-141 (SC); Asian participants will receive a single SC dose of ABBV-141.	Drug: ABBV-141; Infusion; intravenous (IV); Drug: ABBV-141; Injection; subcutaneous (SC)
Placebo Comparator: Part 2, Placebo for ABBV-141 (SC); Asian participants will receive a single SC dose of placebo for ABBV-141.	Drug: Placebo for ABBV-141; Infusion; IV; Drug: Placebo for ABBV-141; Injection; SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of ABBV-141	Cmax of ABBV-141 will be assessed.	Up to Day 85
Time to Cmax (Tmax) of ABBV-141	Tmax of ABBV-141 will be assessed.	Up to Day 85
Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt)	AUCt of ABBV-141 will be determined.	Up to Day 85
AUC of ABBV-141 from Time 0 to Infinity (AUCinf)	AUCinf of ABBV-141 will be assessed.	Up to Day 85
Terminal Phase Elimination Rate Constant (β) of ABBV-141	Terminal phase elimination rate constant (β) of ABBV-141 will be assessed.	Up to Day 85
Terminal Phase Elimination Half-life (t1/2) of ABBV-141	Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.	Up to Day 85
Dose Normalized Cmax of ABBV-141	Dose normalized Cmax of ABBV-141 will be assessed.	Up to Day 85
Dose Normalized AUC of ABBV-141	Dose normalized AUC of ABBV-141 will be assessed.	Up to Day 85
Number of Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Baseline to Day 85

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteers; ABBV-141
• Other Study ID Numbers: M24-693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No