ABBV-313 safety and tolerability in healthy adults
Official 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
Run by AbbVie · NCT07673120 · Data updated 2026-11-12
This study tests single and multiple doses of ABBV-313 in healthy adults to see how safe it is and how the body handles it, compared with placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 2 sites (Anaheim, California and 1 other locations) |
| Status | Recruiting |
| Started | June 24, 2026 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07673120 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged typically 18 years and older with BMI 18.0–29.9 kg/m2 and no significant medical history or recent exposure to ABBV-313.
✕Probably not a fit
Individuals with recent illnesses, significant allergies, or prior ABBV-313 exposure within the last 300 days may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1, interventional trial evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult volunteers. Participants are randomized to receive ABBV-313 or placebo and are closely monitored through dosing and follow-up to assess how the drug behaves in the body and any immune responses. Eligibility requires good general health and a BMI between 18.0 and 29.9 kg/m2, with several exclusion criteria to minimize risk. The study is sponsored by AbbVie with sites in Anaheim, California, and Grayslake, Illinois.
Why it matters
Potential benefit: Participants may not directly benefit, but the study could help determine safe and effective dosing for future trials.
How similar studies have gone: Phase 1 studies of similar monoclonal antibodies have shown that careful dose escalation and monitoring can establish safety and pharmacokinetic profiles.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
CenExel Act- Anaheim Clinical Trials /ID# 285208
Anaheim, California, United States Recruiting -
Acpru /Id# 283495
Grayslake, Illinois, United States Recruiting
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.