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ABBV-701

Phase 2

Crohn's Disease | Small molecule | Other |AbbVie Inc.|Trials Updated: Mar 2, 2026

ABBV-701 development status

Highest phase Phase 2 (NCT07697456)
Phase scored for ABBVPhase 1
Registered trials 2 across 1 sponsor since Mar 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

ABBV-701 clinical trials

ABBV-701 · 1 trial · 1 indication

Phase 1 1
NCT06895343A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Subcutaneous or Intravenous Doses of ABBV-701 in Healthy Adult Western and Asian ParticipantsHealthy Volunteer
ACTIVE NOT_RECRUITING100 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Subcutaneous or Intravenous Doses of ABBV-701 in Healthy Adult Western and Asian Participants
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Study Endpoints

Primary Endpoints

Number of Participants Experiencing Adverse Events
Up to approximately 47 weeks

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Maximum Plasma Concentration (Cmax) of ABBV-701
Up to approximately 47 weeks

Cmax of ABBV-701

Time to Cmax (Tmax) of ABBV-701
Up to approximately 47 weeks

Tmax of ABBV-701

Apparent terminal phase elimination rate constant (β) of ABBV-701
Up to approximately 47 weeks

(β) of ABBV-701

Terminal Phase Elimination Half-Life (t1/2) of ABBV-701
Up to approximately 47 weeks

(t1/2) of ABBV-701

Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-701
Up to approximately 47 weeks

AUCt of ABBV-701

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-701
Up to approximately 47 weeks

AUCinf of ABBV-701

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part 1: Group 1 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose A or placebo.
Part 1: Group 2 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose B or placebo.
Part 1: Group 3 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose C or placebo.
Part 1: Group 4 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose D or placebo.
Part 1: Group 5 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose E or placebo.
Part 2: Group 6 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose E or placebo.
Part 2: Group 7 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose E or placebo.
Part 3: Group 8 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose C or placebo.
Part 3: Group 9 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose E or placebo.
Part 3: Group 10 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose F or placebo.
Part 4: Group 11 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose F or placebo.
Part 4: Group 12 ABBV-701 or PlaceboEXPERIMENTALParticipants will receive a single dose of either ABBV-701 Dose F or placebo.

Interventions

NameTypeDescription
ABBV-701DRUGSubcutaneous
PlaceboDRUGSubcutaneous
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Body weight is ≥ 35 kg and BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG * Part 2 and Part 4 only:...

Countries:United States
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Frequently asked questions about ABBV-701

What is ABBV-701?

ABBV-701 is an investigational small molecule being developed by AbbVie Inc. for Crohn's disease. It is currently in Phase 1 clinical development, meaning it has not been approved by the FDA and remains under study. Only one clinical trial of ABBV-701 has been recorded to date.

What is ABBV-701 used for in Crohn's disease?

ABBV-701 is being developed as a potential treatment for Crohn's disease, an inflammatory condition of the digestive tract. It is investigational and has not been approved for any indication. The only trial recorded for ABBV-701 so far enrolled healthy adult volunteers rather than patients with Crohn's disease.

Who makes ABBV-701?

ABBV-701 is developed by AbbVie Inc., the pharmaceutical company that trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the ABBV-701 clinical program, which is currently at the Phase 1 stage of development.

What phase is ABBV-701 in?

ABBV-701 is in Phase 1 clinical development. It is an investigational small molecule and is not FDA approved. The Phase 1 program consists of one active trial that is no longer recruiting participants, and no trials of ABBV-701 have been completed.

What clinical trials is ABBV-701 in?

ABBV-701 is being studied in one Phase 1 trial, NCT06895343, titled a study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single ascending subcutaneous or intravenous doses of ABBV-701 in healthy adult Western and Asian participants. The trial is active but not recruiting, enrolled 100 participants, and is conducted in the United States.

Is the ABBV-701 trial randomized and blinded?

Yes. The Phase 1 trial of ABBV-701, NCT06895343, is a randomized, double-blind, controlled study. It enrolled 100 healthy adult volunteers aged 18 years and older of all sexes, and it evaluates single ascending subcutaneous or intravenous doses of ABBV-701 in Western and Asian participants.