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PF-06410293 PFS, PF-06410293 PFP

Phase 1

Healthy Subjects | Unknown | Other |Pfizer, Inc.|Last Updated: Jun 6, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment164

FDA Designations

No designations recorded

Clinical trial landscape

PF-06410293 PFS, PF-06410293 PFP · 1 trial · 1 indication

Phase 1 1
NCT02572245A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult SubjectsHealthy Subjects
COMPLETED164 Analytics
PHASE1COMPLETED
A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum serum concentration (Cmax)
Day 1 - Day 15
Area under the concentration curve (AUC 0-2wk)
Day 1-Day 15

Secondary Endpoints

Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose
Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection
Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose
1, 3, 8, 12 and 24 hours post injection
Time to reach the maximum serum concentration (Tmax)
Day 1 - Day 43
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-06410293 PFS (Prefilled Syringe)ACTIVE_COMPARATORPF-06410293 40 mg administered by Prefilled Syringe (PFS)
PF-06410293 PFP (Prefilled Pen)ACTIVE_COMPARATORPF-06410293 40 mg administered by Prefilled pen

Interventions

NameTypeDescription
PF-06410293 PFSDEVICEPF-06410293 40 mg administered subcutaneously by Prefilled syringe
PF-06410293 PFPDEVICEPF-06410293 40 mg administered subcutaneously by prefilled pen
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy female subjects and/or male subjects, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood ...

Countries:United States
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Frequently asked questions about PF-06410293 PFS, PF-06410293 PFP

What is PF-06410293 PFS, PF-06410293 PFP used for?

PF-06410293 PFS, PF-06410293 PFP is an investigational drug being studied in healthy adult subjects. It is administered subcutaneously using a prefilled syringe or a prefilled pen. The drug is currently in Phase 1 clinical development and is not approved for any medical condition.

Who makes PF-06410293 PFS, PF-06410293 PFP?

Pfizer, Inc. (NYSE: PFE) is developing PF-06410293 PFS, PF-06410293 PFP. The company conducted a Phase 1 clinical trial to evaluate the drug's administration via prefilled syringe or prefilled pen in healthy subjects.

What phase is PF-06410293 PFS, PF-06410293 PFP in?

PF-06410293 PFS, PF-06410293 PFP is in Phase 1 clinical development. A single Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities for any use.

What clinical trials is PF-06410293 PFS, PF-06410293 PFP in?

PF-06410293 PFS, PF-06410293 PFP was studied in clinical trial NCT02572245, titled 'A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects.' This Phase 1 trial enrolled 164 participants in the United States and has been completed.

Is PF-06410293 PFS, PF-06410293 PFP the same as PF-06410293?

PF-06410293 PFS and PF-06410293 PFP are formulations of the drug PF-06410293. The PFS and PFP designations refer to the delivery devices: prefilled syringe and prefilled pen, respectively. The clinical trial NCT02572245 evaluated both formulations in healthy subjects.