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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07673120

Enrollment

Registered

2026-06-29

Start date

2026-06-24

Completion date

2028-02-01

Last updated

2026-07-24

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

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers, ABBV-313

Brief summary

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.

Interventions

DRUGABBV-313

Injection

DRUGPlacebo

Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com844-663-3742

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026