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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: ABBV-142

Study type: Interventional

Funder types: Industry

Identifiers

NCT06774313

M25-265

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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74 participants in 9 patient groups

Part 1: Group 1

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-142

Drug: ABBV-142

Drug: Placebo

Part 1: Group 2

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-142

Drug: ABBV-142

Drug: Placebo

Part 1: Group 3

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-142

Drug: ABBV-142

Drug: Placebo

Part 1: Group 4

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-142

Drug: ABBV-142

Drug: Placebo

Part 1: Group 5 (Optional)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-142

Drug: ABBV-142

Drug: Placebo

Part 2: Group 6

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-142

Drug: ABBV-142

Drug: Placebo

Part 2: Group 7

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-142

Drug: ABBV-142

Drug: Placebo

Part 3: Group 8

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-142

Drug: ABBV-142

Drug: Placebo

Part 3: Group 9

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-142

Drug: ABBV-142

Drug: Placebo