NCT07673120 · AbbVie
A Study to Assess Safety, Tolerability, and How Single and Multiple Injections or Infusions of ABBV-313 Affects the Body of Adult Participants
What this study is about
The objective of this study is to assess the safety, tolerability, how the drug moves through the body, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants.
View original scientific description
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
DRUG
ABBV-313
Injection
DRUG
Placebo
Injection
DRUG
ABBV-313
Infusion
DRUG
Placebo
Infusion
Primary outcome measures
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.
Maximum Observed Plasma Concentration (Cmax) of ABBV-313
Time frame: Up to Approximately Day 329
Cmax of ABBV-313.
Time to Cmax (Tmax) of ABBV-313
Time frame: Up to Approximately Day 329
Tmax of ABBV-313.
Terminal Phase Elimination Rate Constant (Beta) of ABBV-313
Time frame: Up to Approximately Day 329
Beta of ABBV-313.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-313
Time frame: 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
Time frame: Up to Approximately Day 329
AUCt of ABBV-313.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Anaheim, California
- Grayslake, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 28, 2026 · Source of record for eligibility and locations