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ABBV-859

Phase 1

Undisclosed | Small molecule | Other |AbbVie Inc.|Trials Updated: Aug 3, 2026

ABBV-859 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

ABBV-859 clinical trials

ABBV-859 · 1 trial · 1 indication

Phase 1 1
NCT07736638A Study to Assess the Safety, Tolerability and How Single Ascending Doses of ABBV-859 Moves Through the Body of Healthy Adult ParticipantsHealthy Volunteer
RECRUITING64 Analytics
PHASE1RECRUITING
A Study to Assess the Safety, Tolerability and How Single Ascending Doses of ABBV-859 Moves Through the Body of Healthy Adult Participants
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events (AEs)
Up to 99 Days

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.

Maximum Observed Serum Concentration (Cmax) of ABBV-859
Up to 99 Days

Cmax of ABBV-859

Time to Cmax (Tmax) of ABBV-859
Up to 99 Days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-859
Up to 99 Days

Beta of ABBV-859

Terminal Phase Elimination Half-Life (t1/2) of ABBV-859
Up to 99 Days

t1/2 of ABBV-859

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-859
Up to 99 Days

AUCt of ABBV-859

AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-859
Up to 99 Days

AUCinf of ABBV-859

Apparent Clearance (CL/F) ABBV-859
Up to 99 Days

CL/F of ABBV-859

Antidrug Antibody (ADA)
Up to 99 Days

Incidence and concentration of anti-drug antibodies.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALParticipants will receive either ABBV-859 single Dose A, or the Placebo equivalent, on Study Day 1
Group 2EXPERIMENTALParticipants will receive either ABBV-859 single Dose B, or the Placebo equivalent, on Study Day 1
Group 3EXPERIMENTALParticipants will receive either ABBV-859 single Dose C, or the Placebo equivalent, on Study Day 1
Group 4EXPERIMENTALParticipants will receive either ABBV-859 single Dose D, or the Placebo equivalent, on Study Day 1
Group 5EXPERIMENTALParticipants will receive either ABBV-859 single Dose E, or the Placebo equivalent, on Study Day 1
Group 6EXPERIMENTALParticipants will receive either ABBV-859 single Dose F, or the Placebo equivalent, on Study Day 1
Group 7EXPERIMENTALParticipants will receive either ABBV-859 single Dose G, or the Placebo equivalent, on Study Day 1
Group 8EXPERIMENTALParticipants will receive either ABBV-859 single Dose H, or the Placebo equivalent, on Study Day 1

Interventions

NameTypeDescription
ABBV-859DRUGOral Tablet
Placebo for ABBV-859DRUGOral Tablet
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. * Body Mass Index (BMI) is \>= 18.0 to \<= 32 kg/m2 after...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 3, 2026NCT07736638Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 3, 2026NCT07736638Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 30, 2026NCT07736638NEW_TRIAL: changed
LOWJul 30, 2026NCT07736638NEW_TRIAL: changed

Frequently asked questions about ABBV-859

What is ABBV-859?

ABBV-859 is an investigational small molecule drug being developed by AbbVie Inc. It is currently in Phase 1 clinical development and has not been approved by the FDA. Its first human study is a single ascending dose trial in healthy adult volunteers, which is designed to assess safety, tolerability, and how the drug moves through the body.

Who makes ABBV-859?

ABBV-859 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the ongoing Phase 1 study of the compound.

What phase is ABBV-859 in?

ABBV-859 is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. The only registered trial of ABBV-859 is a Phase 1 study, and no later-phase trials have been registered.

What clinical trials is ABBV-859 in?

ABBV-859 is being studied in one clinical trial, NCT07736638, titled A Study to Assess the Safety, Tolerability and How Single Ascending Doses of ABBV-859 Moves Through the Body of Healthy Adult Participants. The trial is currently recruiting, is randomized, double-blind, and controlled, and plans to enroll 64 healthy adult volunteers in the United States.

What is ABBV-859 used for?

ABBV-859 is not yet used to treat any condition. It is an investigational drug in Phase 1 testing, and its only registered trial enrolls healthy adult volunteers rather than patients with a specific disease. No approved indication has been established for ABBV-859.