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NCT Number: NCT07570147

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Ascending Doses of ABBV-1451 Infusions and Injections in Healthy Adult Participants

The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-1451 after single ascending doses in healthy adult volunteers.

Recruiting

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Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 282128

Grayslake, Illinois, 60030, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
  • Applies to Part 2 only:
  • For Japanese participants:

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

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

Exclusion criteria

  • History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
  • History of any clinically significant sensitivity or allergy to any medication or food.
  • 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 treatment.

Treatment and study plan

ABBV-1451

Drug

Injection

Placebo

Other

Injection

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Approximately Day 211

    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. The investigator assesses the relationship of each event to the use of study.

  2. Maximum Observed Plasma Concentration (Cmax) of ABBV-1451

    Time frame: Up to Approximately Day 211

    Cmax of ABBV-1451.

  3. Time to Cmax (Tmax) of ABBV-1451

    Time frame: Up to Approximately Day 211

    Tmax of ABBV-1451.

  4. Terminal Phase Elimination Rate Constant (β) of ABBV-1451

    Time frame: Up to Approximately Day 211

    β of ABBV-1451.

  5. Terminal Phase Elimination Half-Life (t1/2) of ABBV-1451

    Time frame: Up to Approximately Day 211

    t1/2 of ABBV-1451.

  6. Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-1451

    Time frame: Up to Approximately Day 211

    AUCt of ABBV-1451.

  7. Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-1451

    Time frame: Up to Approximately Day 211

    AUCinf of ABBV-1451.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A First in Human, Single Ascending Dose Study of ABBV-1451 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Healthy Subjects and in Japanese and Han Chinese Healthy Subjects

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 28, 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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