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ABBV-701

Phase 1

Healthy Volunteer | Small molecule | Other |AbbVie Inc.|Last Updated: Mar 2, 2026

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

Clinical trial landscape

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 used for?

ABBV-701 is an investigational small molecule being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with a single active trial evaluating its safety, tolerability, pharmacokinetics, and immunogenicity in healthy adult participants.

Who makes ABBV-701?

ABBV-701 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 in healthy volunteers.

What phase is ABBV-701 in?

ABBV-701 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is currently being studied in a single active Phase 1 trial involving healthy volunteers.

What clinical trials is ABBV-701 in?

ABBV-701 is being evaluated in one Phase 1 clinical trial, identified as NCT06895343. This study is assessing the safety, tolerability, pharmacokinetics, and immunogenicity of single ascending subcutaneous or intravenous doses of ABBV-701 in healthy adult Western and Asian participants.

Is ABBV-701 being studied in a randomized controlled trial?

Yes, the Phase 1 trial of ABBV-701 is randomized, double-blind, and controlled. The study, NCT06895343, is enrolling 100 healthy adult participants in the United States and is currently active but not recruiting.