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ABBV-701

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 ParticipantsPHASE1 ACTIVE NOT_RECRUITING 100Apr 3, 2025Nov 1, 2026Mar 2, 20262 United States
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06895343primaryCompletionDate: changed
LOWMay 24, 2026NCT06895343studyFirstPostDate: changed