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AGG-523

Phase 1

Healthy Subjects | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Dec 5, 2007

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00380900Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in HealthyPHASE1 COMPLETED -Jul 1, 2006Feb 1, 2007Dec 5, 20071 United States
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Study Endpoints
Primary Endpoints
Assess the safety of multiple doses of AGG-523 administered to subjects.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelFACTORIAL
PurposeTREATMENT
Interventions
NameTypeDescription
AGG-523DRUG -
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men or women, aged 18 to 40 years and subjects with osteoarthritis of the knee, aged 40 to 75 years. * Women must be of non-childbearing potential, defined as surgically sterile with documentation of ultrasound. * Must be nonsmoker or smoke less than 10 cigarettes per ...

Countries:United States
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