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Completed

NCT Number: NCT06774313

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

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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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 271899

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-142

Drug

Intravenous (IV) Infusion

Placebo

Drug

IV Infusion

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 120

    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.

  2. Maximum Observed Serum Concentration (Cmax) of ABBV-142

    Time frame: Up to Day 120

    Cmax of ABBV-142 will be assessed.

  3. Time to Cmax (Tmax) of ABBV-142

    Time frame: Up to Day 120

    Tmax of ABBV-142 will be assessed.

  4. Area Under the Serum Concentration-time Curve (AUC) of ABBV-142 from Time 0 to the Time of Last Measurable Concentration (AUCt)

    Time frame: Up to Day 120

    AUCt of ABBV-142 will be determined.

  5. AUC of ABBV-142 from Time 0 to Infinity (AUCinf)

    Time frame: Up to Day 120

    AUCinf of ABBV-142 will be assessed.

  6. Terminal Phase Elimination Rate Constant (β) of ABBV-142

    Time frame: Up to Day 120

    Terminal phase elimination rate constant (β) of ABBV-142 will be assessed.

  7. Terminal Phase Elimination Half-life (t1/2) of ABBV-142

    Time frame: Up to Day 120

    Terminal phase elimination half-life (t1/2) of ABBV-142 will be assessed.

  8. Dose Normalized Cmax of ABBV-142

    Time frame: Up to Day 120

    Dose normalized Cmax of ABBV-142 will be assessed.

  9. Dose Normalized AUC of ABBV-142

    Time frame: Up to Day 120

    Dose normalized AUC of ABBV-142 will be assessed.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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