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

NCT06774313 | Completed Phase 1 FDA Drug

• 1 other identifier: M25-265
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-142

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (9)

Part 1: Group 1

EXPERIMENTAL

Participants will receive ABBV-142 Dose A or Placebo on Day 1.

Drug: ABBV-142; Drug: Placebo

Part 1: Group 2

EXPERIMENTAL

Participants will receive ABBV-142 Dose B or Placebo on Day 1.

Drug: ABBV-142; Drug: Placebo

Part 1: Group 3

EXPERIMENTAL

Participants will receive ABBV-142 Dose C or Placebo on Day 1.

Drug: ABBV-142; Drug: Placebo

Part 1: Group 4

EXPERIMENTAL

Participants will receive ABBV-142 Dose D or Placebo on Day 1.

Drug: ABBV-142; Drug: Placebo

Part 1: Group 5 (Optional)

EXPERIMENTAL

Participants will receive ABBV-142 Dose TBD or Placebo on Day 1.

Drug: ABBV-142; Drug: Placebo

Part 2: Group 6

EXPERIMENTAL

Participants will receive ABBV-142 Dose B or Placebo on Day 1.

Drug: ABBV-142; Drug: Placebo

Part 2: Group 7

EXPERIMENTAL

Participants will receive ABBV-142 Dose C or Placebo on Day 1.

Drug: ABBV-142; Drug: Placebo

Part 3: Group 8

EXPERIMENTAL

Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.

Drug: ABBV-142; Drug: Placebo

Part 3: Group 9

EXPERIMENTAL

Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.

Drug: ABBV-142; Drug: Placebo

Interventions

ABBV-142 DRUG

Intravenous (IV) Infusion

Part 1: Group 1; Part 1: Group 2; Part 1: Group 3; Part 1: Group 4; Part 1: Group 5 (Optional); Part 3: Group 8; Part 3: Group 9

Placebo DRUG

IV Infusion

Part 1: Group 1; Part 1: Group 2; Part 1: Group 3; Part 1: Group 4; Part 1: Group 5 (Optional); Part 3: Group 8; Part 3: Group 9

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 271899

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: January 22, 2025
• Primary Completion: April 8, 2026
• Study Completion: April 8, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)