A Study to Assess the Adverse Events and How Subcutaneous (SC) Injections and Intravenous (IV) Infusions of ABBV-142 Move Through the Body of Healthy Adult Participants

A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses of ABBV-142 in Healthy Adult Subjects and Single Doses of ABBV-142 in Healthy Adult Asian Subjects

This study is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted efficacious exposures can be safely achieved in humans.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: ABBV-142; Drug: ABBV-142

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 271899

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

All Parts:

• Volunteers in general good health.

Part 3, ONLY:

HAN CHINESE Participants:

• Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health.
• First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent.
• Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent.

OR

JAPANESE Participants:

• Participant must be first- or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health.
• First-generation participants will have been born in Japan to two parents and four grandparents born in Japan and are of full Japanese descent.
• Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.

Exclusion Criteria:

• History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
• Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
• History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Group 1; Participants will receive ABBV-142 Dose A or Placebo on Day 1.	Drug: Placebo; IV Infusion; Drug: Placebo; SC Injection; Drug: ABBV-142; Intravenous (IV) Infusion; Drug: ABBV-142; Subcutaneous (SC) Injection
Experimental: Part 1: Group 2; Participants will receive ABBV-142 Dose B or Placebo on Day 1.	Drug: Placebo; IV Infusion; Drug: Placebo; SC Injection; Drug: ABBV-142; Intravenous (IV) Infusion; Drug: ABBV-142; Subcutaneous (SC) Injection
Experimental: Part 1: Group 3; Participants will receive ABBV-142 Dose C or Placebo on Day 1.	Drug: Placebo; IV Infusion; Drug: Placebo; SC Injection; Drug: ABBV-142; Intravenous (IV) Infusion; Drug: ABBV-142; Subcutaneous (SC) Injection
Experimental: Part 1: Group 4; Participants will receive ABBV-142 Dose D or Placebo on Day 1.	Drug: Placebo; IV Infusion; Drug: Placebo; SC Injection; Drug: ABBV-142; Intravenous (IV) Infusion; Drug: ABBV-142; Subcutaneous (SC) Injection
Experimental: Part 1: Group 5 (Optional); Participants will receive ABBV-142 Dose TBD or Placebo on Day 1.	Drug: Placebo; IV Infusion; Drug: Placebo; SC Injection; Drug: ABBV-142; Intravenous (IV) Infusion; Drug: ABBV-142; Subcutaneous (SC) Injection
Experimental: Part 2: Group 6; Participants will receive ABBV-142 Dose B or Placebo on Day 1.	Drug: Placebo; IV Infusion; Drug: Placebo; SC Injection; Drug: ABBV-142; Intravenous (IV) Infusion; Drug: ABBV-142; Subcutaneous (SC) Injection
Experimental: Part 2: Group 7; Participants will receive ABBV-142 Dose C or Placebo on Day 1.	Drug: Placebo; IV Infusion; Drug: Placebo; SC Injection; Drug: ABBV-142; Intravenous (IV) Infusion; Drug: ABBV-142; Subcutaneous (SC) Injection
Experimental: Part 3: Group 8; Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.	Drug: Placebo; IV Infusion; Drug: Placebo; SC Injection; Drug: ABBV-142; Intravenous (IV) Infusion; Drug: ABBV-142; Subcutaneous (SC) Injection
Experimental: Part 3: Group 9; Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.	Drug: Placebo; IV Infusion; Drug: Placebo; SC Injection; Drug: ABBV-142; Intravenous (IV) Infusion; Drug: ABBV-142; Subcutaneous (SC) Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to Day 120
Maximum Observed Serum Concentration (Cmax) of ABBV-142	Cmax of ABBV-142 will be assessed.	Up to Day 120
Time to Cmax (Tmax) of ABBV-142	Tmax of ABBV-142 will be assessed.	Up to Day 120
Area Under the Serum Concentration-time Curve (AUC) of ABBV-142 from Time 0 to the Time of Last Measurable Concentration (AUCt)	AUCt of ABBV-142 will be determined.	Up to Day 120
AUC of ABBV-142 from Time 0 to Infinity (AUCinf)	AUCinf of ABBV-142 will be assessed.	Up to Day 120
Terminal Phase Elimination Rate Constant (β) of ABBV-142	Terminal phase elimination rate constant (β) of ABBV-142 will be assessed.	Up to Day 120
Terminal Phase Elimination Half-life (t1/2) of ABBV-142	Terminal phase elimination half-life (t1/2) of ABBV-142 will be assessed.	Up to Day 120
Dose Normalized Cmax of ABBV-142	Dose normalized Cmax of ABBV-142 will be assessed.	Up to Day 120
Dose Normalized AUC of ABBV-142	Dose normalized AUC of ABBV-142 will be assessed.	Up to Day 120

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 22, 2025
• Primary Completion (Actual): April 8, 2026
• Study Completion (Actual): April 8, 2026

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteer; ABBV-142
• Other Study ID Numbers: M25-265

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