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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07141199

Enrollment

Registered

2025-08-26

Start date

2025-09-02

Completion date

2026-04-01

Last updated

2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer, ABBV-8736

Brief summary

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.

Interventions

DRUGABBV-8736

Intravenous (IV) Infusion

DRUGPlacebo

IV Infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Terminal Phase Elimination Half-Life (t1/2) of ABBV-8736	Up to Approximately 113 Days	t1/2 of ABBV-8736.
Clearance (CL) for Intravenous (IV) Dosing	Up to Approximately 113 Days	CL for IV dosing.
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of ABBV-8736	Up to Approximately 113 Days	AUCtau of ABBV-8736.
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-8736	Up to Approximately 113 Days	Ctrough of ABBV-8736.
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-8736	Up to Approximately 113 Days	β of ABBV-8736.
Number of Participants with Adverse Events (AEs)	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.
Maximum Observed Concentration (Cmax) of ABBV-8736	Up to Approximately 113 Days	Cmax of ABBV-8736.
Time to Cmax (Tmax) of ABBV-8736	Up to Approximately 113 Days	Tmax of ABBV-8736.
Immunogenicity of ABBV-8736 as Determined by Anti-Drug Antibodies (ADAs)	Up to Approximately 113 Days	Incidence and concentrations of ADAs. Neutralizing ADAs (NAb) may be evaluated.

Countries

United States

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026