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CompletedNCT07425899Updated Aug 4, 2026

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 interventional study of ABBV-722 and Upadacitinib in Healthy Volunteer, sponsored by AbbVie. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by AbbVie · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • Healthy Volunteer
  • ABBV-722
  • Upadacitinib
03

In context

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Period 1: Group 1

    Participants will receive multiple doses of Upadacitinib

    Drug: Upadacitinib

  • Experimental
    Period 1: Group 2

    Participants will receive multiple doses of Upadacitinib

    Drug: Upadacitinib

  • Experimental
    Period 2: Group 1

    Participants will receive multiple doses of ABBV-722

    Drug: ABBV-722

  • Experimental
    Period 2: Group 2

    Participants will receive multiple doses of ABBV-722

    Drug: ABBV-722

  • Experimental
    Period 3: Group 1

    Participants will receive multiple doses of ABBV-722 and Upadacitinib

    Drug: ABBV-722 · Drug: Upadacitinib

  • Experimental
    Period 3: Group 2

    Participants will receive multiple doses of ABBV-722 and Upadacitinib

    Drug: ABBV-722 · Drug: Upadacitinib

Interventions

  • DrugABBV-722

    Oral

  • DrugUpadacitinib

    Oral

06

What researchers measure

Primary outcomes

  1. Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722

    Cmax,ss of ABBV-722

    Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3

  2. Time to maximum observed plasma concentration (Tmax) of ABBV-722

    Tmax of ABBV-722

    Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3

  3. Area under curve over the dosing interval at steady state (AUCtau,ss) of ABBV-722

    AUCtau,ss of ABBV-722

    Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3

  4. Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of ABBV-722

    Ctrough,ss of ABBV-722

    Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3

  5. Maximum observed plasma concentration at steady state (Cmax,ss) of Upadacitinib

    Cmax,ss of Upadacitinib

    Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3

  6. Time to maximum observed plasma concentration (Tmax) of Upadacitinib

    Tmax of Upadacitinib

    Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3

  7. Area under curve over the dosing interval at steady state (AUCtau,ss) of Upadacitinib

    AUCtau,ss of Upadacitinib

    Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3

  8. Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of Upadacitinib

    Ctrough,ss of Upadacitinib

    Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3

  9. 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.

    Time frame: Approximately up to 91 days

07

Study locations

1 site
  • Acpru /Id# 279285
    Grayslake, Illinois 60030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07425899
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Feb 23, 2026
Start date
Feb 26, 2026
Primary completion
Jun 5, 2026
Completion
Jun 5, 2026
Last update
Aug 4, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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