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ABBV-859

Phase 1

Healthy Volunteer | Small molecule | Other |AbbVie Inc.|Last Updated: Aug 3, 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

Clinical trial landscape

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 used for?

ABBV-859 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development to assess its safety, tolerability, and how it moves through the body. It is not approved for any condition and is being evaluated in a clinical trial setting.

Who makes ABBV-859?

ABBV-859 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and pharmacokinetics in healthy adult participants.

What phase is ABBV-859 in?

ABBV-859 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the safety, tolerability, and how single ascending doses of the drug move through the body.

What clinical trials is ABBV-859 in?

ABBV-859 is being studied in one active Phase 1 clinical trial, identified as NCT07736638. This randomized, double-blind, controlled study is recruiting 64 healthy adult participants in the United States to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of the drug.

Is ABBV-859 FDA approved?

ABBV-859 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is designed to assess its safety and how it is processed by the body in healthy volunteers, which is an early stage of the drug development process.