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ABT-874

Phase 1

Healthy | Small molecule | Other |Abbott Laboratories|Last Updated: Nov 8, 2010

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 Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00870948Phase 1 BA Study, Single Center With Healthy VolunteersPHASE1 COMPLETED 75Jan 1, 2009 -Nov 8, 20101 United States
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Study Endpoints
Primary Endpoints
Bioavailability following single dose
Hours: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 1008, 1344 for Regimens A, C, D and additional hours 4 & 8 for Regimen B and hours 0.5 and 6 hours for Regimen E
Secondary Endpoints
AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study
Through Day 85 (and / or 45 days after study drug stoppped)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Regimen AEXPERIMENTALOne 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected subcutaneously in the abdominal region at a 45 degree angle
Regimen BEXPERIMENTALOne 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected IV in an arm vein
Regimen CEXPERIMENTALOne 100 mg ABT 874 (reconstituted lyophilized powder from the 3000 L process) injected subcutaneously in the abdominal region at a 45 degree angle
Regimen DEXPERIMENTALOne 100 mg ABT-874 (reconstituted lyophilized powder from the 1000 L process) injected subcutaneously in the abdominal region at a 45 degree angle
Regimen EEXPERIMENTAL700 mg ABT-874 (reconstituted lyophilized powder from the 3000 L process) in 100 mL 5% dextrose solution IV infusion in an arm vein
Interventions
NameTypeDescription
ABT-874DRUGSee Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects must be healthy Exclusion Criteria: * Subjects who are not healthy, enrolled in another study, or who have received ABT-874 previously.

Countries:United States
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