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NCT Number: NCT07673120

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

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.

Recruiting

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 283495

Grayslake, Illinois, 60030, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-313

Drug

Injection

Placebo

Drug

Injection

Primary outcomes

  1. 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.

  2. Maximum Observed Plasma Concentration (Cmax) of ABBV-313

    Time frame: Up to Approximately Day 329

    Cmax of ABBV-313.

  3. Time to Cmax (Tmax) of ABBV-313

    Time frame: Up to Approximately Day 329

    Tmax of ABBV-313.

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

    Time frame: Up to Approximately Day 329

    Beta of ABBV-313.

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

    Time frame: Up to Approximately Day 329

    t1/2 of ABBV-313.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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