RecruitingPhase 1

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

United States64 participantsStarted 2026-06-22

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Adverse Events (AEs)

Timeframe: Up to Approximately Day 329

Maximum Observed Plasma Concentration (Cmax) of ABBV-313

Timeframe: Up to Approximately Day 329

Time to Cmax (Tmax) of ABBV-313

Timeframe: Up to Approximately Day 329

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

Timeframe: Up to Approximately Day 329

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

Timeframe: 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

Timeframe: Up to Approximately Day 329

Trial details

NCT IDNCT07673120

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02

Contact for this trial

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants with Adverse Events (AEs)

Timeframe: Up to Approximately Day 329

Maximum Observed Plasma Concentration (Cmax) of ABBV-313

Timeframe: Up to Approximately Day 329

Time to Cmax (Tmax) of ABBV-313

Timeframe: Up to Approximately Day 329

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

Timeframe: Up to Approximately Day 329

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

Timeframe: 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

Timeframe: Up to Approximately Day 329