A Study to Assess Safety, Tolerability, and How Single and Multiple Injections or Infusions of ABBV-313 Affects the Body of Adult Participants

June 23, 2026 updated by: AbbVie

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses and Multiple Doses of ABBV-313

The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Acpru /Id# 283495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI is >= 18.0 to <= 29.9 kg/m2 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 any clinically significant sensitivity or allergy to any medication or food.
  • History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
  • Participant has prior exposure to ABBV-313 within the past 300 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1, Group 1: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
Drug: Placebo
Injection
Drug: Placebo
Infusion
Drug: ABBV-313
Injection
Drug: ABBV-313
Infusion
Experimental: Part 1, Group 2: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
Drug: Placebo
Injection
Drug: Placebo
Infusion
Drug: ABBV-313
Injection
Drug: ABBV-313
Infusion
Experimental: Part 1, Group 3: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
Drug: Placebo
Injection
Drug: Placebo
Infusion
Drug: ABBV-313
Injection
Drug: ABBV-313
Infusion
Experimental: Part 1, Group 4: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
Drug: Placebo
Injection
Drug: Placebo
Infusion
Drug: ABBV-313
Injection
Drug: ABBV-313
Infusion
Experimental: Part 1, Group 5: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
Drug: Placebo
Injection
Drug: Placebo
Infusion
Drug: ABBV-313
Injection
Drug: ABBV-313
Infusion
Experimental: Part 1, Group 6: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
Drug: Placebo
Injection
Drug: Placebo
Infusion
Drug: ABBV-313
Injection
Drug: ABBV-313
Infusion
Experimental: Part 2, Group 7: ABBV-313 or Placebo
Participants will receive multiple doses of ABBV-313 or Placebo
Drug: Placebo
Injection
Drug: Placebo
Infusion
Drug: ABBV-313
Injection
Drug: ABBV-313
Infusion
Experimental: Part 2, Group 8: ABBV-313 or Placebo
Participants will receive multiple doses of ABBV-313 or Placebo
Drug: Placebo
Injection
Drug: Placebo
Infusion
Drug: ABBV-313
Injection
Drug: ABBV-313
Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Approximately Day 329
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 Day 329
Maximum Observed Plasma Concentration (Cmax) of ABBV-313
Time Frame: Up to Approximately Day 329
Cmax of ABBV-313.
Up to Approximately Day 329
Time to Cmax (Tmax) of ABBV-313
Time Frame: Up to Approximately Day 329
Tmax of ABBV-313.
Up to Approximately Day 329
Terminal Phase Elimination Rate Constant (Beta) of ABBV-313
Time Frame: Up to Approximately Day 329
Beta of ABBV-313.
Up to Approximately Day 329
Terminal Phase Elimination Half-Life (t1/2) of ABBV-313
Time Frame: Up to Approximately Day 329
t1/2 of ABBV-313.
Up to Approximately Day 329
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-313
Time Frame: Up to Approximately Day 329
AUCt of ABBV-313.
Up to Approximately Day 329

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 22, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M26-216

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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