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PF-04603629

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

PF-04603629 · 1 trial · 1 indication

Phase 1 1
NCT00638313Single-Dose Study Of PF-04603629 In Type 2 Diabetic SubjectsDiabetes Mellitus, Type 2
COMPLETED71 Analytics
PHASE1COMPLETED
Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects
Diabetes Mellitus, Type 2Unlock trial analytics

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 to 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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Frequently asked questions about PF-04603629

What is PF-04603629 used for?

PF-04603629 is an investigational monoclonal antibody being developed for the treatment of Type 2 Diabetes Mellitus. It is a metabolic therapeutic that has been studied in a Phase 1 clinical trial. The drug is not yet approved and remains in clinical development.

Who makes PF-04603629?

PF-04603629 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company conducted a Phase 1 clinical trial of the drug in the United States.

What phase is PF-04603629 in?

PF-04603629 is in Phase 1 clinical development. A single-dose study in Type 2 diabetic subjects has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF-04603629 in?

PF-04603629 has been studied in one completed Phase 1 clinical trial, identified as NCT00638313. This was a single-dose, randomized, double-blind, placebo-controlled study in 71 Type 2 diabetic subjects in the United States.

Is PF-04603629 the same as any other drug?

No alternative names for PF-04603629 have been disclosed. The drug is identified solely by its code name PF-04603629 in clinical trial records.