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ABP-671

Phase 1

Gout | Small molecule | Musculoskeletal |Co-Diagnostics, Inc.|Last Updated: Jun 23, 2020

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04303039Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy SubjectsPHASE1 COMPLETED 12May 22, 2020Jun 19, 2020Jun 23, 20201 United States
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Study Endpoints
Primary Endpoints
Plasma ABP-671 Concentration
72 hours

At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.

Secondary Endpoints
Serum Uric Acid Concentration
72 hours
Serum Creatinine Concentration
72 hours
Urine Uric Acid Concentration
72 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTALSingle 1.0 mg dose of ABP-671 in the fasted state.
Treatment BEXPERIMENTALSingle 1.0 mg dose of ABP-671 in the fed state, after a standardized breakfast.
Interventions
NameTypeDescription
ABP-671DRUGABP-671 Tablet 1.0 mg
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female aged 18 to 60 years, inclusive * Healthy * Subjects must have the serum uric acid level at screening ≥ 3.7 mg/dL to ≤ 7.0 mg/dL for males, and ≥ 2.3 mg/dL to ≤ 6.0 mg/dL for females. * Subjects must have a Body Mass Index (BMI) between 18 and 35 kg/m2 at screeni...

Countries:United States
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Competitive Landscape -Gout 5 trials