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ABBV-722

Phase 1

Healthy Volunteer | Small molecule | Other |AbbVie Inc.|Last Updated: Aug 28, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment111

FDA Designations

No designations recorded

Clinical trial landscape

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
ACTIVE NOT_RECRUITING12 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
PHASE1ACTIVE NOT_RECRUITING
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)

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
MEDIUMJul 20, 2026NCT07567781Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 20, 2026NCT07567781Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 25, 2026NCT06673238Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 25, 2026NCT06673238Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 25, 2026NCT06673238Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about ABBV-722

What is ABBV-722 used for?

ABBV-722 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with trials assessing how the drug moves through the body, its safety, tolerability, and effects when taken with food or other medications. It is not approved for any condition.

Who makes ABBV-722?

ABBV-722 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy adult participants.

What phase is ABBV-722 in?

ABBV-722 is in Phase 1 clinical development. All four registered trials are Phase 1 studies, with three completed and one active but not recruiting. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ABBV-722 in?

ABBV-722 has been studied in four Phase 1 trials. NCT06673238 assessed single and multiple ascending doses of oral capsules. NCT07361367 evaluated a tablet form with and without food. NCT07425899 studied ABBV-722 with upadacitinib. NCT07599761 is assessing the effect of itraconazole on ABBV-722.

Is ABBV-722 being studied in patients or healthy volunteers?

ABBV-722 is being studied exclusively in healthy adult volunteers. All four Phase 1 trials enroll healthy participants aged 18 years and older, with no patient populations included. The studies are designed to evaluate the drug's pharmacokinetics, safety, and tolerability in this population.