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Completed

NCT Number: NCT07141199

A Study to Evaluate Adverse Events, How the Drug is Tolerated, and How the Drug Moves Through the Body of Intravenous Infusions of ABBV-8736 in Adult Healthy Volunteers

The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity following multiple intravenous (IV) ascending doses of ABBV-8736 in healthy adult participants.

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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# 277377

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

  • Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
  • 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.

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.
  • Prior exposure to a TREM1 agent.

Treatment and study plan

ABBV-8736

Drug

Intravenous (IV) Infusion

Placebo

Drug

IV Infusion

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Approximately 113 Days

    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 Concentration (Cmax) of ABBV-8736

    Time frame: Up to Approximately 113 Days

    Cmax of ABBV-8736.

  3. Time to Cmax (Tmax) of ABBV-8736

    Time frame: Up to Approximately 113 Days

    Tmax of ABBV-8736.

  4. Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of ABBV-8736

    Time frame: Up to Approximately 113 Days

    AUCtau of ABBV-8736.

  5. Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-8736

    Time frame: Up to Approximately 113 Days

    Ctrough of ABBV-8736.

  6. Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-8736

    Time frame: Up to Approximately 113 Days

    β of ABBV-8736.

  7. Terminal Phase Elimination Half-Life (t1/2) of ABBV-8736

    Time frame: Up to Approximately 113 Days

    t1/2 of ABBV-8736.

  8. Clearance (CL) for Intravenous (IV) Dosing

    Time frame: Up to Approximately 113 Days

    CL for IV dosing.

  9. Immunogenicity of ABBV-8736 as Determined by Anti-Drug Antibodies (ADAs)

    Time frame: Up to Approximately 113 Days

    Incidence and concentrations of ADAs. Neutralizing ADAs (NAb) may be evaluated.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-8736 After Multiple Ascending Doses in Healthy Adult Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Apr 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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