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PF-04603629

Phase 1

Diabetes Mellitus, Type 2 | Monoclonal antibody | Metabolic |Pfizer, Inc.|Last Updated: Jul 31, 2009

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00638313Single-Dose Study Of PF-04603629 In Type 2 Diabetic SubjectsPHASE1 COMPLETED 71 — — Aug 1, 2007Feb 1, 2008Jul 31, 20092 United States
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Study Endpoints
Primary Endpoints
To characterize the pharmacokinetics of PF-04603629 in serum after administration, under fasted conditions, of single, escalating, subcutaneous doses of PF-04603629 to adult subjects with T2DM.
1 week per dose group
To characterize the pharmacodynamic effect (glucose AUC lowering) of single, escalating, subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.
1 week per dose group
To evaluate the safety and tolerability of escalating, single subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.
1 week per dose group
Secondary Endpoints
No secondary outcomes listed in the protocol.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
PF-04603629EXPERIMENTAL -
Interventions
NameTypeDescription
PlaceboBIOLOGICALSubjects will be given either Placebo or PF-04603629.
PF-04603629BIOLOGICALSubjects will be given either Placebo or PF-04603629. The specific dose of PF-04603629 given depended on the Cohort to which the patient was assigned. Doses administered ranged from 1 mg to 70 mg.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Type 2 diabetes mellitus * Hb A1c lower or equal to 11% Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug all...

Countries:United States
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