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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

NCT ID: NCT06774313

Last Updated: 2025-07-03

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-22

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1: Group 1

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

Group Type EXPERIMENTAL

ABBV-142

Intervention Type DRUG

Intravenous (IV) Infusion

Placebo

Intervention Type DRUG

IV Infusion

Part 1: Group 2

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

Group Type EXPERIMENTAL

ABBV-142

Intervention Type DRUG

Intravenous (IV) Infusion

Placebo

Intervention Type DRUG

IV Infusion

Part 1: Group 3

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

Group Type EXPERIMENTAL

ABBV-142

Intervention Type DRUG

Intravenous (IV) Infusion

Placebo

Intervention Type DRUG

IV Infusion

Part 1: Group 4

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

Group Type EXPERIMENTAL

ABBV-142

Intervention Type DRUG

Intravenous (IV) Infusion

Placebo

Intervention Type DRUG

IV Infusion

Part 1: Group 5 (Optional)

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

Group Type EXPERIMENTAL

ABBV-142

Intervention Type DRUG

Intravenous (IV) Infusion

Placebo

Intervention Type DRUG

IV Infusion

Part 2: Group 6

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

Group Type EXPERIMENTAL

ABBV-142

Intervention Type DRUG

Subcutaneous (SC) Injection

Placebo

Intervention Type DRUG

SC Injection

Part 2: Group 7

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

Group Type EXPERIMENTAL

ABBV-142

Intervention Type DRUG

Subcutaneous (SC) Injection

Placebo

Intervention Type DRUG

SC Injection

Part 3: Group 8

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

Group Type EXPERIMENTAL

ABBV-142

Intervention Type DRUG

Intravenous (IV) Infusion

Placebo

Intervention Type DRUG

IV Infusion

Part 3: Group 9

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

Group Type EXPERIMENTAL

ABBV-142

Intervention Type DRUG

Intravenous (IV) Infusion

Placebo

Intervention Type DRUG

IV Infusion

Interventions

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ABBV-142

Intravenous (IV) Infusion

Intervention Type DRUG

ABBV-142

Subcutaneous (SC) Injection

Intervention Type DRUG

Placebo

IV Infusion

Intervention Type DRUG

Placebo

SC Injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Acpru /Id# 271899

Grayslake, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ABBVIE CALL CENTER

Role: CONTACT

[email protected]
844-663-3742

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M25-265

Related Info

Other Identifiers

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M25-265

Identifier Type: -

Identifier Source: org_study_id

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