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Risankizumab Dose A

Phase 1

Healthy Volunteers | Small molecule | Other |AbbVie Inc.|Last Updated: Apr 28, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment198

FDA Designations

No designations recorded

Clinical trial landscape

Risankizumab Dose A · 1 trial · 1 indication

Phase 1 1
NCT05567029Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.Healthy Volunteers
COMPLETED198 Analytics
PHASE1COMPLETED
Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.
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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 to 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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Frequently asked questions about Risankizumab Dose A

What is Risankizumab Dose A used for?

Risankizumab Dose A is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial evaluating its relative bioavailability in healthy adult participants. The drug is not approved for any indication and remains under clinical investigation.

Who makes Risankizumab Dose A?

Risankizumab Dose A is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical trials to evaluate the drug's properties in healthy volunteers.

What phase is Risankizumab Dose A in?

Risankizumab Dose A is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is Risankizumab Dose A in?

Risankizumab Dose A has one completed clinical trial, NCT05567029, titled "Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers." This Phase 1 study enrolled 198 participants in the United States and was completed.

Is Risankizumab Dose A the same as Risankizumab?

Risankizumab Dose A is a specific formulation or presentation of risankizumab being studied for its relative bioavailability. The trial NCT05567029 compares two drug product presentations of risankizumab in healthy volunteers to evaluate how they are absorbed and processed by the body.