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ABBV-066

Phase 1

Healthy | Small molecule | Other |AbbVie Inc.|Last Updated: Jul 6, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-066 · 1 trial · 1 indication

Phase 1 1
NCT02596217Safety, Tolerability and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male VolunteersHealthy
COMPLETED80 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of subjects with drug-related adverse events
Up to 144 days after screening

Secondary Endpoints

Time from dosing to the maximum plasma concentration of the analyte in plasma (tmax)
Up to 144 days after randomization
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of the last quantifiable plasma concentration (AUC0-tz)
Up to 144 days after randomization
Maximum measured plasma concentration of the analyte in plasma (Cmax)
Up to 144 days after randomization
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Stage 1 (low dose SC)EXPERIMENTALLow dose administered by subcutaneous (SC) injection
Stage 1 (medium dose SC)EXPERIMENTALMedium dose administered by subcutaneous (SC) injection
Stage 1 (high dose SC)EXPERIMENTALHigh dose administered by subcutaneous (SC) injection
Stage 2 (low dose IV)EXPERIMENTALLow dose administered by intraveneous (IV) infusion
Stage 2 (medium dose IV)EXPERIMENTALMedium dose administered by intraveneous (IV) infusion
Stage 2 (high dose IV)EXPERIMENTALHigh dose administered by intraveneous (IV) infusion
Placebo SC (Stage1)PLACEBO_COMPARATORPlacebo administered by subcutaneous (SC) injection
Placebo IV (Stage2)PLACEBO_COMPARATORPlacebo administered by intraveneous (IV) infusion

Interventions

NameTypeDescription
ABBV-066DRUGSC injection
PlaceboDRUGSC injection (stage 1)
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion criteria: 1. Healthy male subjects according to the investigator¿s assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests 2. Chinese ethnicity, Japanese ethnicity, or Caucasian according to the fol...

Countries:JapanSouth Korea
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Frequently asked questions about ABBV-066

What is ABBV-066?

ABBV-066 is an investigational small molecule being developed by AbbVie Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and it is not yet approved for any medical condition.

What is ABBV-066 used for?

ABBV-066 is being studied for use in healthy volunteers, primarily to assess its safety, tolerability, and pharmacokinetics. It is not intended for treatment of any specific disease at this stage of development.

Who makes ABBV-066?

ABBV-066 is developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker ABBV.

What phase is ABBV-066 in?

ABBV-066 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities.

What clinical trials is ABBV-066 in?

ABBV-066 was studied in a completed Phase 1 trial with the identifier NCT02596217. This trial evaluated the safety, tolerability, and pharmacokinetics of the drug in healthy Asian and Caucasian male volunteers, enrolling 80 participants in Japan and South Korea.

Is ABBV-066 the same as risankizumab?

Yes, ABBV-066 is also known as risankizumab and BI 655066. The completed Phase 1 trial NCT02596217 explicitly refers to the drug as BI 655066/ABBV-066 (Risankizumab).