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

NCT07141199 | Completed Phase 1 FDA Drug

• 1 other identifier: M25-918
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-8736

Outcome Measures

Primary Outcomes (9)

• 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 Approximately 113 Days

• Maximum Observed Concentration (Cmax) of ABBV-8736

  Cmax of ABBV-8736.

  Up to Approximately 113 Days

• Time to Cmax (Tmax) of ABBV-8736

  Tmax of ABBV-8736.

  Up to Approximately 113 Days

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

  AUCtau of ABBV-8736.

  Up to Approximately 113 Days

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

  Ctrough of ABBV-8736.

  Up to Approximately 113 Days

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

  β of ABBV-8736.

  Up to Approximately 113 Days

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

  t1/2 of ABBV-8736.

  Up to Approximately 113 Days

• Clearance (CL) for Intravenous (IV) Dosing

  CL for IV dosing.

  Up to Approximately 113 Days

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

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

  Up to Approximately 113 Days

Study Arms (4)

Group 1: Dose A of ABBV-8736

EXPERIMENTAL

Participants will receive intravenous (IV) ABBV-8736 dose A every 2 weeks for a total of 3 doses.

Drug: ABBV-8736

Group 1: Dose A of ABBV-8736 Placebo

PLACEBO COMPARATOR

Participants will receive IV ABBV-8736 placebo dose A every 2 weeks for a total of 3 doses.

Drug: Placebo

Group 2: Dose B of ABBV-8736

EXPERIMENTAL

Participants will receive IV ABBV-8736 dose B every 2 weeks for a total of 3 doses.

Drug: ABBV-8736

Group 2: Dose B of ABBV-8736 Placebo

PLACEBO COMPARATOR

Participants will receive IV ABBV-8736 placebo dose B every 2 weeks for a total of 3 doses.

Drug: Placebo

Interventions

ABBV-8736 DRUG

Intravenous (IV) Infusion

Group 1: Dose A of ABBV-8736; Group 2: Dose B of ABBV-8736

Placebo DRUG

IV Infusion

Group 1: Dose A of ABBV-8736 Placebo; Group 2: Dose B of ABBV-8736 Placebo

Eligibility Criteria

• Age: 18 Years - 55 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/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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 277377

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: September 2, 2025
• Primary Completion: March 23, 2026
• Study Completion: March 23, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)