NCT07673120

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
19mo left

Started Jun 2026

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Feb 2028

First Submitted

Initial submission to the registry

June 23, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

June 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

June 23, 2026

Last Update Submit

July 23, 2026

Conditions

Healthy Volunteers

Keywords

Healthy VolunteersABBV-313

Outcome Measures

Primary Outcomes (6)

  • 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 Day 329

  • Maximum Observed Plasma Concentration (Cmax) of ABBV-313

    Cmax of ABBV-313.

    Up to Approximately Day 329

  • Time to Cmax (Tmax) of ABBV-313

    Tmax of ABBV-313.

    Up to Approximately Day 329

  • Terminal Phase Elimination Rate Constant (Beta) of ABBV-313

    Beta of ABBV-313.

    Up to Approximately Day 329

  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-313

    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

    AUCt of ABBV-313.

    Up to Approximately Day 329

Study Arms (8)

Part 1, Group 1: ABBV-313 or Placebo

EXPERIMENTAL

Participants will receive a single dose of ABBV-313 or Placebo

Drug: ABBV-313Drug: Placebo

Part 1, Group 2: ABBV-313 or Placebo

EXPERIMENTAL

Participants will receive a single dose of ABBV-313 or Placebo

Drug: ABBV-313Drug: Placebo

Part 1, Group 3: ABBV-313 or Placebo

EXPERIMENTAL

Participants will receive a single dose of ABBV-313 or Placebo

Drug: ABBV-313Drug: Placebo

Part 1, Group 4: ABBV-313 or Placebo

EXPERIMENTAL

Participants will receive a single dose of ABBV-313 or Placebo

Drug: ABBV-313Drug: Placebo

Part 1, Group 5: ABBV-313 or Placebo

EXPERIMENTAL

Participants will receive a single dose of ABBV-313 or Placebo

Drug: ABBV-313Drug: Placebo

Part 1, Group 6: ABBV-313 or Placebo

EXPERIMENTAL

Participants will receive a single dose of ABBV-313 or Placebo

Drug: ABBV-313Drug: Placebo

Part 2, Group 7: ABBV-313 or Placebo

EXPERIMENTAL

Participants will receive multiple doses of ABBV-313 or Placebo

Drug: ABBV-313Drug: Placebo

Part 2, Group 8: ABBV-313 or Placebo

EXPERIMENTAL

Participants will receive multiple doses of ABBV-313 or Placebo

Drug: ABBV-313Drug: Placebo

Interventions

PlaceboDRUG

Injection

Part 1, Group 1: ABBV-313 or PlaceboPart 1, Group 2: ABBV-313 or PlaceboPart 1, Group 5: ABBV-313 or PlaceboPart 2, Group 7: ABBV-313 or PlaceboPart 2, Group 8: ABBV-313 or Placebo
ABBV-313DRUG

Injection

Part 1, Group 1: ABBV-313 or PlaceboPart 1, Group 2: ABBV-313 or PlaceboPart 1, Group 5: ABBV-313 or PlaceboPart 2, Group 7: ABBV-313 or PlaceboPart 2, Group 8: ABBV-313 or Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acpru /Id# 283495

Grayslake, Illinois, 60030, United States

RECRUITING

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742abbvieclinicaltrials@abbvie.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start

June 24, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)