Healthy VolunteersPhase 1NCT07843693
A Study to Evaluate the Safety and Pharmacokinetics of Multiple Doses Upadacitinib, Tofacitinib, and Baricitinib in Healthy Adult Volunteers
A Phase 1 study testing Upadacitinib, Tofacitinib and Baricitinib in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
This is a Phase 1, open label, five arm study to evaluate the pharmacodynamic effects of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Upadacitinib, Tofacitinib and Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2026to Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 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 Exam (PE), vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).
- A female must not be pregnant, or breastfeeding and is not considering becoming pregnant, cryopreserving her eggs or donating eggs during the study or for approximately 30 days after the last dose of study treatment.
Who cannot join
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster, one or more prior episodes of disseminated herpes simplex (including eczema herpeticum) or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- 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.
- Participant has prior exposure to upadacitinib, tofacitinib or baricitinib within the past 90 days.
- Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis.
- Participant has used any medications, vitamins and/or herbal supplements within the 2-week period prior to study treatment administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Acpru /Id# 286751
Grayslake, Illinois, 60030
About this study
Official title: A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers
This is a Phase 1, open label, five arm study to evaluate the pharmacodynamic effects of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Upadacitinib, Tofacitinib, Baricitinib
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Oral Tablet
TofacitinibDrug
Oral Tablet
BaricitinibDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Multiple doses of Upadacitinib | Experimental | Upadacitinib will be administered once daily Receives: Drug: Upadacitinib |
| Arm 2: Multiple doses of Tofacitinib | Experimental | Tofacitinib will be administered twice daily Receives: Drug: Tofacitinib |
| Arm 3: Multiple doses of Upadacitinib | Experimental | Upadacitinib will be administered once daily Receives: Drug: Upadacitinib |
| Arm 4: Multiple doses of Tofacitinib | Experimental | Tofacitinib will be administered twice daily Receives: Drug: Tofacitinib |
| Arm 5: Multiple doses of Baricitinib | Experimental | Baricitinib will be administered once daily Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Measured: Up to 44 Days
Average plasma concentration (Cavg) of Upadacitinib
Cavg of Upadacitinib
Measured: Up to 44 Days
Average plasma concentration (Cavg) of Tofacitinib
Cavg of Tofacitinib
Measured: Up to 44 Days
Average plasma concentration (Cavg) of Baricitinib
Cavg of Baricitinib
Measured: Up to 44 Days
Area under the concentration-time curve over 24 hours (AUC24) of Upadacitinib
AUC24 of Upadacitinib
Measured: Up to 44 Days
Area under the concentration-time curve over 24 hours (AUC24) of Tofacitinib
AUC24 of Tofacitinib
Measured: Up to 44 Days
Area under the concentration-time curve over 24 hours (AUC24) of Baricitinib
AUC24 of Baricitinib
Measured: Up to 44 Days
Maximum Observed Plasma Concentration (Cmax) of Upadacitinib
Cmax of Upadacitinib
Measured: Up to 44 Days
Maximum Observed Plasma Concentration (Cmax) of Tofacitinib
Cmax of Tofacitinib
Measured: Up to 44 Days
Maximum Observed Plasma Concentration (Cmax) of Baricitinib
Cmax of Baricitinib
Measured: Up to 44 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start26 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843693
- Sponsor's protocol ID
- M26-625
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No