Healthy VolunteerPhase 1NCT07425899
A Phase 1 Study of the Safety and How the Body Processes ABBV-722 and Upadacitinib After Multiple Oral Doses in Healthy Adult Participants
A Phase 1 study testing ABBV-722 and Upadacitinib in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
This is a Phase 1 study to investigate safety and pharmacokinetics of ABBV-722 and Upadacitinib following multiple oral doses 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 Volunteer
- What is being tested?
- ABBV-722 and Upadacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 5 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 is a Phase 1 study to investigate safety and pharmacokinetics of ABBV-722 and Upadacitinib following multiple oral doses in healthy adult participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-722, Upadacitinib
- Keywords
- Healthy Volunteer, ABBV-722, Upadacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-722Drug
Oral
UpadacitinibDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Group 1 | Experimental | Participants will receive multiple doses of Upadacitinib Receives: Drug: Upadacitinib |
| Period 1: Group 2 | Experimental | Participants will receive multiple doses of Upadacitinib Receives: Drug: Upadacitinib |
| Period 2: Group 1 | Experimental | Participants will receive multiple doses of ABBV-722 Receives: Drug: ABBV-722 |
| Period 2: Group 2 | Experimental | Participants will receive multiple doses of ABBV-722 Receives: Drug: ABBV-722 |
| Period 3: Group 1 | Experimental | Participants will receive multiple doses of ABBV-722 and Upadacitinib Receives: Drug: ABBV-722; Drug: Upadacitinib |
| Period 3: Group 2 | Experimental | Participants will receive multiple doses of ABBV-722 and Upadacitinib Receives: Drug: ABBV-722; Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722
Cmax,ss of ABBV-722
Measured: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Time to maximum observed plasma concentration (Tmax) of ABBV-722
Tmax of ABBV-722
Measured: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Area under curve over the dosing interval at steady state (AUCtau,ss) of ABBV-722
AUCtau,ss of ABBV-722
Measured: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of ABBV-722
Ctrough,ss of ABBV-722
Measured: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Maximum observed plasma concentration at steady state (Cmax,ss) of Upadacitinib
Cmax,ss of Upadacitinib
Measured: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Time to maximum observed plasma concentration (Tmax) of Upadacitinib
Tmax of Upadacitinib
Measured: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Area under curve over the dosing interval at steady state (AUCtau,ss) of Upadacitinib
AUCtau,ss of Upadacitinib
Measured: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of Upadacitinib
Ctrough,ss of Upadacitinib
Measured: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Number of Participants with Adverse Events (AEs)
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.
Measured: Approximately up to 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start26 Feb 2026
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
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
- NCT07425899
- Sponsor's protocol ID
- M25-431
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2026
- Last updated
- 4 Aug 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of ABBV-722 and Upadacitinib Following Multiple Oral Doses in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07425899
- Acronym / sponsor ID
- M25-431
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-722, Upadacitinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 23 Feb 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 study to investigate safety and pharmacokinetics of ABBV-722 and Upadacitinib following multiple oral doses in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Period 1: Group 1 | Experimental | Drug: UpadacitinibParticipants will receive multiple doses of Upadacitinib |
| Period 1: Group 2 | Experimental | Drug: UpadacitinibParticipants will receive multiple doses of Upadacitinib |
| Period 2: Group 1 | Experimental | Drug: ABBV-722Participants will receive multiple doses of ABBV-722 |
| Period 2: Group 2 | Experimental | Drug: ABBV-722Participants will receive multiple doses of ABBV-722 |
| Period 3: Group 1 | Experimental | Drug: ABBV-722, Drug: UpadacitinibParticipants will receive multiple doses of ABBV-722 and Upadacitinib |
| Period 3: Group 2 | Experimental | Drug: ABBV-722, Drug: UpadacitinibParticipants will receive multiple doses of ABBV-722 and Upadacitinib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| ABBV-722Oral | Drug | Period 2: Group 1, Period 2: Group 2, Period 3: Group 1, Period 3: Group 2 |
| UpadacitinibOral | Drug | Period 1: Group 1, Period 1: Group 2, Period 3: Group 1, Period 3: Group 2 |
Primary outcome
Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722
Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Cmax,ss of ABBV-722
Time to maximum observed plasma concentration (Tmax) of ABBV-722
Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Tmax of ABBV-722
Area under curve over the dosing interval at steady state (AUCtau,ss) of ABBV-722
Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
AUCtau,ss of ABBV-722
Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of ABBV-722
Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Ctrough,ss of ABBV-722
Maximum observed plasma concentration at steady state (Cmax,ss) of Upadacitinib
Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Cmax,ss of Upadacitinib
Time to maximum observed plasma concentration (Tmax) of Upadacitinib
Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Tmax of Upadacitinib
Area under curve over the dosing interval at steady state (AUCtau,ss) of Upadacitinib
Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
AUCtau,ss of Upadacitinib
Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of Upadacitinib
Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Ctrough,ss of Upadacitinib
Number of Participants with Adverse Events (AEs)
Time frame: Approximately up to 91 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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. This study is not recruiting at the moment.
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 ABBV-722 and Upadacitinib in people with Healthy Volunteer, 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 4 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722 (time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3). The study lists 9 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 4 Aug 2026.