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ABBV-722

Phase 1

Undisclosed | Small molecule | Other |AbbVie Inc.|Trials Updated: Sep 30, 2026

ABBV-722 development status

Highest phase Phase 1
Registered trials 6 across 1 sponsor since Nov 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials5
Total Enrollment146

FDA Designations

No designations recorded

ABBV-722 clinical trials

ABBV-722 · 5 trials · 2 indications

Phase 1 5
NCT07599761A Phase 1 Study to Assess the Effect of Itraconazole on ABBV-722 in Healthy Adult ParticipantsHealthy Volunteers
COMPLETED12 Analytics
NCT07567781A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults.Healthy Volunteers
COMPLETED12 Analytics
NCT07425899A Phase 1 Study of the Safety and How the Body Processes ABBV-722 and Upadacitinib After Multiple Oral Doses in Healthy Adult ParticipantsHealthy Volunteer
COMPLETED16 Analytics
NCT07361367A Phase 1 Study of a Tablet Form of ABBV-722 Taken With and Without Food in Healthy Adult ParticipantsHealthy Volunteers
COMPLETED11 Analytics
NCT06673238A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian ParticipantsHealthy Volunteer
COMPLETED95 Analytics
PHASE1COMPLETED
A Phase 1 Study to Assess the Effect of Itraconazole on ABBV-722 in Healthy Adult Participants
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults.
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Phase 1 Study of the Safety and How the Body Processes ABBV-722 and Upadacitinib After Multiple Oral Doses in Healthy Adult Participants
Healthy VolunteerUnlock trial analytics
PHASE1COMPLETED
A Phase 1 Study of a Tablet Form of ABBV-722 Taken With and Without Food in Healthy Adult Participants
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

Cmax of ABBV-722

Time to Cmax (Tmax) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

Tmax of ABBV-722

Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

AUCt of ABBV-722

Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

AUCinf of ABBV-722

Terminal Phase Elimination Rate Constant (β) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

β of ABBV-722

Terminal Phase Elimination Half-Life (t1/2) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

t1/2 of ABBV-722

Number of Participants with Adverse Events (AEs)
Up to Approximately 45 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.

Maximum Observed Plasma Concentration (Cmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Time to Cmax (Tmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Terminal Phase Elimination Rate Constant (β) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Terminal Phase Elimination Half-Life (t1/2) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722
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
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
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
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
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
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
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
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 Reported During Safety Evaluations
Up to Day 44

Safety evaluations will include AE monitoring, vital sign measurements (including orthostatic blood pressure and pulse rate), ECG variables, and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration. Clinically significant abnormal changes in physical examination findings will be reported as AEs.

Maximum Plasma Concentration (Cmax) of ABBV-722
Up to Day 21

Cmax of ABBV-722.

For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722
Up to Day 8

AUCt of ABBV-722.

For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722
Up to Day 8

AUCinf of ABBV-722

For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722
Up to Day 21

Ctrough of ABBV-722.

For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722
Up to Day 21

AUC from AUCtau following the first and last doses of ABBV-722.

Terminal Phase Elimination Rate Constant (Beta) of ABBV-722
Up to Day 21

Beta of ABBV-722.

Dose Normalized Cmax
Up to Day 21

Dose normalized Cmax.

Dose Normalized AUCs
Up to Day 21

Dose normalized AUCs.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Period 1 & 2EXPERIMENTALIn Period 1, participants will receive a single dose of ABBV-722. In Period 2, participants will receive multiple daily doses of Itraconazole and a single dose of ABBV-722.
Period 1: Group 1EXPERIMENTALParticipants will receive multiple doses of Upadacitinib
Period 1: Group 2EXPERIMENTALParticipants will receive multiple doses of Upadacitinib
Period 2: Group 1EXPERIMENTALParticipants will receive multiple doses of ABBV-722
Period 2: Group 2EXPERIMENTALParticipants will receive multiple doses of ABBV-722
Period 3: Group 1EXPERIMENTALParticipants will receive multiple doses of ABBV-722 and Upadacitinib
Period 3: Group 2EXPERIMENTALParticipants will receive multiple doses of ABBV-722 and Upadacitinib
Period 1: Single Dose AEXPERIMENTALSingle dose will be administered under fasted conditions
Period 2: Single Dose AEXPERIMENTALSingle dose will be administered under fed (high-fat meal) conditions
Period 3: Single Dose BEXPERIMENTALSingle dose will be administered under fasted conditions
Part 1: Group 1EXPERIMENTALParticipants will receive a single dose of either ABBV-722 Dose A or placebo.
Part 1: Group 2EXPERIMENTALParticipants will receive a single dose of either ABBV-722 Dose B or placebo.
Part 1: Group 3EXPERIMENTALParticipants will receive a single dose of either ABBV-722 Dose C or placebo.
Part 1: Group 4EXPERIMENTALParticipants will receive a single dose of either ABBV-722 Dose TBD or placebo.
Part 1: Group 5EXPERIMENTALParticipants will receive a single dose of either ABBV-722 Dose TBD or placebo.
Part 2: Group 6EXPERIMENTALParticipants who are Han Chinese will receive a single dose of ABBV-722 Dose D.
Part 2: Group 7EXPERIMENTALParticipants who are Japanese will receive a single dose of ABBV-722 Dose D.
Part 3: Group 8EXPERIMENTALParticipants will receive either ABBV-722 Dose E or placebo for 14 days.
Part 3: Group 9EXPERIMENTALParticipants will receive either ABBV-722 Dose F or placebo for 14 days.
Part 3: Group 10EXPERIMENTALParticipants will receive either ABBV-722 Dose A or placebo for 14 days.
Part 3: Group 11EXPERIMENTALParticipants will receive either ABBV-722 Dose G or placebo for 14 days.
Part 3: Group 12EXPERIMENTALParticipants will receive either ABBV-722 Dose TBD or placebo for 14 days.

Interventions

NameTypeDescription
ABBV-722DRUGOral Tablet
ItraconazoleDRUGOral Capsule
MidazolamDRUGOral Solution
MetforminDRUGOral Tablet
DigoxinDRUGOral Tablet
PitavastatinDRUGOral Tablet
SitagliptinDRUGOral Tablet
UpadacitinibDRUGOral
PlaceboDRUGOral Capsule
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 an...

Countries:United States
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Recent Changes (Last 90 Days)

HIGHSep 30, 2026NCT07599761Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHSep 30, 2026NCT07599761Status: ACTIVE_NOT_RECRUITING → COMPLETED
MEDIUMSep 20, 2026NCT07567781TRIAL_REMOVED: changed
MEDIUMSep 20, 2026NCT07567781TRIAL_REMOVED: changed
MEDIUMSep 20, 2026NCT07567781TRIAL_REMOVED: changed
MEDIUMSep 4, 2026NCT07425899TRIAL_REMOVED: changed
MEDIUMSep 4, 2026NCT07425899TRIAL_REMOVED: changed
MEDIUMSep 4, 2026NCT07425899TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT07599761Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 28, 2026NCT07599761Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 27, 2026NCT06673238TRIAL_REMOVED: changed
MEDIUMAug 27, 2026NCT06673238TRIAL_REMOVED: changed
MEDIUMAug 27, 2026NCT06673238TRIAL_REMOVED: changed
HIGHAug 20, 2026NCT07567781Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHAug 20, 2026NCT07567781Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHAug 4, 2026NCT07425899Status: RECRUITING → COMPLETED
HIGHAug 4, 2026NCT07425899Status: RECRUITING → COMPLETED
HIGHJul 27, 2026NCT06673238Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 27, 2026NCT06673238Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 27, 2026NCT06673238Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about ABBV-722

What is ABBV-722?

ABBV-722 is an investigational small molecule being developed by AbbVie Inc. It is in Phase 1 clinical development, and its therapeutic indications have not been disclosed. All of its clinical testing to date has been conducted in healthy adult volunteers rather than in patients with a specific disease.

Who makes ABBV-722?

ABBV-722 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the Phase 1 clinical program evaluating the compound in healthy adult participants in the United States.

What phase is ABBV-722 in?

ABBV-722 is in Phase 1 clinical development. Five Phase 1 trials have been completed, and none are currently active. The studies enrolled a total of 146 participants, all healthy adults, and the program has not yet advanced into later-stage testing in patients.

What clinical trials is ABBV-722 in?

ABBV-722 has been studied in five completed Phase 1 trials, including NCT07599761, which assessed the effect of itraconazole on ABBV-722; NCT07567781, which assessed ABBV-722's effect on midazolam, digoxin, pitavastatin, metformin, and sitagliptin levels; NCT07425899, which evaluated ABBV-722 with upadacitinib; and NCT07361367, a food-effect tablet study.

Are the ABBV-722 trials randomized and blinded?

Yes. The ABBV-722 Phase 1 program includes randomized, double-blind, controlled trials. The studies were conducted in healthy adult volunteers in the United States, with participants aged 18 years and older of any sex. Total enrollment across the completed trials was 146 participants.

What is ABBV-722 used for?

The therapeutic indications for ABBV-722 have not been disclosed. The compound is an investigational small molecule in Phase 1 development, and its completed trials were conducted in healthy adult volunteers to evaluate safety, drug interactions, and how the body processes the drug rather than to treat a specific disease.