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ABBV-101

Phase 1

Healthy Volunteer | Small molecule | Other |AbbVie Inc.|Last Updated: Oct 2, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06887010A Study to Assess How Food Affects the Movement of Oral ABBV-101 Through the Body of Healthy Adult ParticipantsPHASE1 COMPLETED 17Mar 25, 2025Sep 16, 2025Oct 2, 20251 United States
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Study Endpoints
Primary Endpoints
Number of Participants Experiencing Adverse Events
Up to approximately 45 days

An adverse event 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

Maximum Observed Plasma Concentration (Cmax) of ABBV-101
Up to approximately 21 days

Maximum observed plasma concentration (Cmax) of ABBV-101

Time to Cmax (Tmax) of ABBV-101
Up to approximately 21 days

Tmax of ABBV-101

Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-101
Up to approximately 21 days

AUC of ABBV-101

Terminal Phase Elimination Half-life (t1/2) of ABBV-101
Up to approximately 21 days

Terminal phase elimination of half-life (t1/2) of ABBV-101

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
ABBV-101: Sequence 1EXPERIMENTALParticipants will receive ABBV-101 under fasting conditions in Period 1 and will receive ABBV-101 under non-fasting conditions in Period 2
ABBV-101: Sequence 2EXPERIMENTALParticipants will receive ABBV-101 under non-fasting conditions in Period 1 and will receive ABBV-101 under fasting conditions in Period 2.
Interventions
NameTypeDescription
ABBV-101DRUGOral: Tablet
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * A condition of general good health, based upon the results of a medical history...

Countries:United States
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