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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers
- ClinicalTrials.gov ID
- NCT07843693
- Acronym / sponsor ID
- M26-625
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Multiple doses of Upadacitinib | Experimental | Drug: UpadacitinibUpadacitinib will be administered once daily |
| Arm 2: Multiple doses of Tofacitinib | Experimental | Drug: TofacitinibTofacitinib will be administered twice daily |
| Arm 3: Multiple doses of Upadacitinib | Experimental | Drug: UpadacitinibUpadacitinib will be administered once daily |
| Arm 4: Multiple doses of Tofacitinib | Experimental | Drug: TofacitinibTofacitinib will be administered twice daily |
| Arm 5: Multiple doses of Baricitinib | Experimental | Drug: BaricitinibBaricitinib will be administered once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibOral Tablet | Drug | Arm 1: Multiple doses of Upadacitinib, Arm 3: Multiple doses of Upadacitinib |
| TofacitinibOral Tablet | Drug | Arm 2: Multiple doses of Tofacitinib, Arm 4: Multiple doses of Tofacitinib |
| BaricitinibOral Tablet | Drug | Arm 5: Multiple doses of Baricitinib |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Time frame: Up to 44 Days
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.
Average plasma concentration (Cavg) of Upadacitinib
Time frame: Up to 44 Days
Cavg of Upadacitinib
Average plasma concentration (Cavg) of Tofacitinib
Time frame: Up to 44 Days
Cavg of Tofacitinib
Average plasma concentration (Cavg) of Baricitinib
Time frame: Up to 44 Days
Cavg of Baricitinib
Area under the concentration-time curve over 24 hours (AUC24) of Upadacitinib
Time frame: Up to 44 Days
AUC24 of Upadacitinib
Area under the concentration-time curve over 24 hours (AUC24) of Tofacitinib
Time frame: Up to 44 Days
AUC24 of Tofacitinib
Area under the concentration-time curve over 24 hours (AUC24) of Baricitinib
Time frame: Up to 44 Days
AUC24 of Baricitinib
Maximum Observed Plasma Concentration (Cmax) of Upadacitinib
Time frame: Up to 44 Days
Cmax of Upadacitinib
Maximum Observed Plasma Concentration (Cmax) of Tofacitinib
Time frame: Up to 44 Days
Cmax of Tofacitinib
Maximum Observed Plasma Concentration (Cmax) of Baricitinib
Time frame: Up to 44 Days
Cmax of Baricitinib
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Upadacitinib, Tofacitinib and Baricitinib in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAE) (time frame: Up to 44 Days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.