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

NCT07413133 | Active Not Recruiting Phase 1

• 1 other identifier: M25-478
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-8736

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Arm 1: Intravenous (IV) ABBV-8736

EXPERIMENTAL

Participants will receive IV ABBV-8736 on Day 1.

Drug: ABBV-8736

Arm 2: Subcutaneous (SC) ABBV-8736

EXPERIMENTAL

Participants will receive SC ABBV-8736 on Day 1.

Drug: ABBV-8736

Interventions

ABBV-8736 DRUG

Intravenous Injection

Arm 1: Intravenous (IV) ABBV-8736

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

CenExel ACT- Anaheim Clinical Trials /ID# 280481

Anaheim, California, 92801, United States

Location

Acpru /Id# 280382

Grayslake, Illinois, 60030, United States

Location

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)