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ABBV-154 Dose Formulation A

Phase 1

ABBV-154 | Small molecule | Other |AbbVie Inc.|Last Updated: Mar 13, 2023

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
RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05556226Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy ParticipantsPHASE1 COMPLETED 40 — — Oct 18, 2022Feb 17, 2023Mar 13, 20232 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
Approximately up to 58 days
Time to Maximum Observed Plasma Concentration (Tmax)
Approximately up to 58 days
Apparent Terminal Phase Elimination Rate Constant (β)
Approximately up to 58 days
The Terminal Phase Elimination Half-Life (t1/2)
Approximately up to 58 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Approximately up to 58 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Approximately up to 58 days
Number of Participants with Adverse Events
Approximately up to 72 days

An adverse event (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. The investigator assesses the relationship of each event to the use of study.

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
ABBV-154 Dose AEXPERIMENTALParticipants will receive subcutaneous dose of ABBV-154 Dose Formulation A.
ABBV-154 Dose BEXPERIMENTALParticipants will receive subcutaneous dose of ABBV-154 Dose Formulation B.
Interventions
NameTypeDescription
ABBV-154 Dose Formulation ADRUGSubcutaneous Injection
ABBV-154 Dose Formulation BDRUGSubcutaneous Injection
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: \- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement. Exclusion Criteria: * Participant using any medications, vitamins and/or herbal supplements, within the 2 week period or 5 half-lives (whichever is...

Countries:United States
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