Recruiting
Phase 1

ABBV-313

Sponsor:

AbbVie

Code:

NCT07673120

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

ABBV-313

Placebo

ABBV-313

Placebo

Study Details

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.

Conditions

Healthy Volunteers

Study ID

NCT07673120

Start date

Jun 24, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Part 1, Group 1: ABBV-313 or Placebo

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

experimental: Part 1, Group 2: ABBV-313 or Placebo

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

experimental: Part 1, Group 3: ABBV-313 or Placebo

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

experimental: Part 1, Group 4: ABBV-313 or Placebo

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

experimental: Part 1, Group 5: ABBV-313 or Placebo

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

experimental: Part 1, Group 6: ABBV-313 or Placebo

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

experimental: Part 2, Group 7: ABBV-313 or Placebo

Participants will receive multiple doses of ABBV-313 or Placebo

experimental: Part 2, Group 8: ABBV-313 or Placebo

Participants will receive multiple doses of ABBV-313 or Placebo

Interventions

ABBV-313

Injection

Placebo

Injection

ABBV-313

Infusion

Placebo

Infusion

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately Day 329 ]
  • Maximum Observed Plasma Concentration (Cmax) of ABBV-313 [ Time Frame: Up to Approximately Day 329 ]
  • Time to Cmax (Tmax) of ABBV-313 [ Time Frame: Up to Approximately Day 329 ]
  • Terminal Phase Elimination Rate Constant (Beta) of ABBV-313 [ Time Frame: Up to Approximately Day 329 ]
  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-313 [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Acpru /Id# 283495

Recruiting

Grayslake, Illinois, United States, 60030

More Information

Sponsor

AbbVie

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Healthy Volunteers
  • ABBV-313

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-24.