A Study to Assess How the Body Absorbs ABBV-8736 Subcutaneous Injections Relative to Intravenous Injections in Adult Healthy Volunteers

A Phase 1 Pharmacokinetic Study in Healthy Adult Volunteers to Evaluate the Bioavailability of ABBV-8736 Following Subcutaneous Administration Relative to Intravenous Administration

The purpose of this study is to assess the pharmacokinetics (PK), bioavailability, immunogenicity, safety, and tolerability of ABBV-8736 following subcutaneous (SC) administration relative to intravenous (IV) administration.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: ABBV-8736; Drug: ABBV-8736

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • CenExel ACT- Anaheim Clinical Trials /ID# 280481
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 280382

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Body weight >= 35 kg.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

• Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements, on a regular basis.
• Participant uses any medications, vitamins and/or herbal supplements within the 14-day period prior to study treatment administration.
• Participant has received any treatment by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study treatment administration.
• Participant has prior exposure to a Triggering Receptor Expressed on Myeloid Cells 1 (TREM1) agent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Intravenous (IV) ABBV-8736; Participants will receive IV ABBV-8736 on Day 1.	Drug: ABBV-8736; Intravenous Injection; Drug: ABBV-8736; Subcutaneous Injection
Experimental: Arm 2: Subcutaneous (SC) ABBV-8736; Participants will receive SC ABBV-8736 on Day 1.	Drug: ABBV-8736; Intravenous Injection; Drug: ABBV-8736; Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	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.	Up to At Least 3 Months
Maximum Observed Serum Concentration (Cmax) of ABBV-8736	Cmax of ABBV-8736.	Up to At Least 3 Months
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-8736	Tmax of ABBV-8736.	Up to At Least 3 Months
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time Last (AUClast) of ABBV-8736	AUClast of ABBV-8736.	Up to At Least 3 Months
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-8736	AUCinf of ABBV-8736.	Up to At Least 3 Months
Terminal Phase Elimination Rate Constant (β) of ABBV-8736	β of ABBV-8736.	Up to At Least 3 Months
Terminal Elimination Half-Life (t1/2) of ABBV-8736	t1/2 of ABBV-8736.	Up to At Least 3 Months
Apparent Clearance of the Analyte in Serum (CL) of ABBV-8736	CL of ABBV-8736.	Up to At Least 3 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteer; ABBV-8736
• Other Study ID Numbers: M25-478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No