Safety and how the body handles ABBV-722 and upadacitinib in healthy adults
A Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of ABBV-722 and Upadacitinib Following Multiple Oral Doses in Healthy Adult Subjects
This tests whether ABBV-722 and upadacitinib are safe and how the body processes them when taken by healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | Upadacitinib |
| Locations | 1 site (Grayslake, Illinois) |
| Trial ID | NCT07425899 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study gives multiple oral doses of ABBV-722 and upadacitinib to healthy adult volunteers to measure safety and pharmacokinetics. Participants undergo screening including labs, ECG, and physical exam, and must meet health and laboratory criteria with no recent serious illness or tobacco use. Investigators will monitor adverse events, vital signs, laboratory tests, and drug concentrations over the dosing period. The study is sponsored by AbbVie and conducted at a single site in Grayslake, Illinois.
Who should consider this trial
Good fit: Healthy adults who meet the protocol's lab and medical criteria, are non-smokers, and have no recent serious illness, infection, or surgery are ideal candidates.
Not a fit: People with active or recent infections, recent hospitalization or surgery, tobacco or nicotine use, certain histories of malignancy, or who cannot avoid prohibited substances are unlikely to benefit from participation.
Why it matters
Potential benefit: If results show good safety and predictable pharmacokinetics, it could support moving these drugs forward to patient studies that test effectiveness.
How similar studies have performed: Upadacitinib has extensive clinical data for inflammatory diseases, but combining it with ABBV-722 and testing both together in healthy volunteers is a relatively novel approach with limited prior public data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Laboratory values meet the criteria specified in the protocol. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). Exclusion Criteria: * 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 drug. * Chronic recurring infection and/or active viral infection. * Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration. * Use of tobacco or nicotine-containing products within 90 days prior to the first dose of study drug. * Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix. * History or evidence of active tuberculosis (TB) disease or latent TB infection * Prior exposure to ABBV-722 within 90 days prior to the first dose of study drug.
Where this trial is running
Grayslake, Illinois
- Acpru /Id# 279285 — Grayslake, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.