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Completed

NCT Number: NCT07425899

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

This is a Phase 1 study to investigate safety and pharmacokinetics of ABBV-722 and Upadacitinib following multiple oral doses in healthy adult participants.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 279285

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-722

Drug

Oral

Upadacitinib

Drug

Oral

Primary outcomes

  1. 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

  2. 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

  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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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