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

NCT07425899 | Recruiting Phase 1 FDA Drug

• 1 other identifier: M25-431
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-722; Upadacitinib

Outcome Measures

Primary Outcomes (9)

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

  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

  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

  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

  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

  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

  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

  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

  Ctrough,ss of Upadacitinib

  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.

  Approximately up to 91 days

Study Arms (6)

Period 1: Group 1

EXPERIMENTAL

Participants will receive multiple doses of Upadacitinib

Drug: Upadacitinib

Period 1: Group 2

EXPERIMENTAL

Participants will receive multiple doses of Upadacitinib

Drug: Upadacitinib

Period 2: Group 1

EXPERIMENTAL

Participants will receive multiple doses of ABBV-722

Drug: ABBV-722

Period 2: Group 2

EXPERIMENTAL

Participants will receive multiple doses of ABBV-722

Drug: ABBV-722

Period 3: Group 1

EXPERIMENTAL

Participants will receive multiple doses of ABBV-722 and Upadacitinib

Drug: ABBV-722; Drug: Upadacitinib

Period 3: Group 2

EXPERIMENTAL

Participants will receive multiple doses of ABBV-722 and Upadacitinib

Drug: ABBV-722; Drug: Upadacitinib

Interventions

ABBV-722 DRUG

Oral

Period 2: Group 1; Period 2: Group 2; Period 3: Group 1; Period 3: Group 2

Upadacitinib DRUG

Oral

Period 1: Group 1; Period 1: Group 2; Period 3: Group 1; Period 3: Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 279285

Grayslake, Illinois, 60030, United States

RECRUITING

MeSH Terms

Interventions

upadacitinib

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)