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Risankizumab Dose A

Phase 1

Healthy Volunteers | Small molecule | Other |AbbVie Inc.|Last Updated: Apr 28, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment198
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05567029Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.PHASE1 COMPLETED 198 — — Sep 28, 2022Apr 20, 2023Apr 28, 20235 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
Approximately up to 113 days
Time to Maximum Observed Plasma Concentration (Tmax)
Approximately up to 113 days
Apparent Terminal Phase Elimination Rate Constant (β)
Approximately up to 113 days
The Terminal Phase Elimination Half-Life (t1/2)
Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Approximately up to 113 days
Number of Participants with Adverse Events
Approximately up to 140 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
Risankizumab Dose AEXPERIMENTALParticipants will receive subcutaneous dose of risankizumab dose A.
Risankizumab Dose BEXPERIMENTALParticipants will receive subcutaneous dose of risankizumab dose B.
Interventions
NameTypeDescription
Risankizumab Dose ADRUGPrefilled Syringe
Risankizumab Dose BDRUGPrefilled Syringe
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: \- Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement. Exclusion Criteria: * Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment. * Intention to perform strenuous exercise to which the participant is unacc...

Countries:United States
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