A Phase 1 Study of the Safety and How the Body Processes ABBV-722 and Upadacitinib After Multiple Oral Doses in Healthy Adult Participants

April 14, 2026 updated by: AbbVie

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Acpru /Id# 279285

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Period 1: Group 1
Participants will receive multiple doses of Upadacitinib
Drug: Upadacitinib
Oral
Experimental: Period 1: Group 2
Participants will receive multiple doses of Upadacitinib
Drug: Upadacitinib
Oral
Experimental: Period 2: Group 1
Participants will receive multiple doses of ABBV-722
Drug: ABBV-722
Oral
Experimental: Period 2: Group 2
Participants will receive multiple doses of ABBV-722
Drug: ABBV-722
Oral
Experimental: Period 3: Group 1
Participants will receive multiple doses of ABBV-722 and Upadacitinib
Drug: Upadacitinib
Oral
Drug: ABBV-722
Oral
Experimental: Period 3: Group 2
Participants will receive multiple doses of ABBV-722 and Upadacitinib
Drug: Upadacitinib
Oral
Drug: ABBV-722
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately up to 91 days
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
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
Time Frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Tmax of ABBV-722
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
Time Frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
AUCtau,ss of ABBV-722
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
Time Frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Ctrough,ss of ABBV-722
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
Time Frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Cmax,ss of Upadacitinib
Up to Day 7 in Period 1 and Up to Day 17 in Period 3
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
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
Time Frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
AUCtau,ss of Upadacitinib
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
Time Frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Ctrough,ss of Upadacitinib
Up to Day 7 in Period 1 and Up to Day 17 in Period 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M25-431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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