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Epoetin Hospira SDV

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: May 17, 2018

Epoetin Hospira SDV development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2018

Epoetin Hospira SDV target and mechanism

Molecular targetEPOR
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Epoetin Hospira SDV clinical trials

Epoetin Hospira SDV · 1 trial · 1 indication

Phase 1 1
NCT03398473A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy SubjectsHealthy
COMPLETED68 Analytics
PHASE1COMPLETED
A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum serum concentration (C max) of PF-06946151 SDV
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Maximum serum concentration (C max) of PF-06946151 MDV
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the serum PF-06946151 SDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the serum PF-06946151 MDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the PF-06946151 SDV concentration-time profile (AUC inf) from time zero extrapolated to infinity
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the PF-06946151 MDV concentration-time profile (AUC inf) from time zero extrapolated to infinity
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]

Secondary Endpoints

Time to reach maximum concentration (T max) of PF-06946151 SDV
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Time to reach maximum concentration (T max) of PF-06946151 MDV
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Elimination half life (T 1/2) of PF-06946151 SDV
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Epoetin Hospira SDVEXPERIMENTALEpoetin Hospira Single Dose Vial (SDV)
Epoetin Hospira MDVEXPERIMENTALEpoetin Hospira Multi-Dose Vial (MDV)

Interventions

NameTypeDescription
Epoetin Hospira SDVDRUGEpoetin Hospira Single Dose Vial
Epoetin Hospira MDVDRUGEpoetin Hospira Multi-Dose Vial
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy female and male subjects who, at time of Screening, are between ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate m...

Countries:United States
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Frequently asked questions about Epoetin Hospira SDV

What is Epoetin Hospira SDV?

Epoetin Hospira SDV is an investigational erythropoiesis-stimulating agent developed by Pfizer, Inc. (NYSE: PFE). It is a single-dose vial formulation of epoetin. The specific clinical indication for this product has not been publicly disclosed. It is in Phase 1 clinical development.

What does Epoetin Hospira SDV target?

Epoetin Hospira SDV targets the erythropoietin receptor (EPOR), where it acts as an agonist. By binding to and activating EPOR, it mimics the action of endogenous erythropoietin, the hormone that regulates red blood cell production. This mechanism is characteristic of erythropoiesis-stimulating agents.

Who makes Epoetin Hospira SDV?

Epoetin Hospira SDV is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company responsible for the clinical development of this single-dose vial formulation of epoetin.

What phase is Epoetin Hospira SDV in?

Epoetin Hospira SDV is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 1 program consists of one completed trial that enrolled 68 healthy volunteers.

What clinical trials is Epoetin Hospira SDV in?

Epoetin Hospira SDV has been studied in one completed Phase 1 trial, NCT03398473. The trial compared the effects of the single-dose vial and multi-dose vial formulations when administered subcutaneously to normal healthy subjects. It enrolled 68 participants in the United States and was randomized and controlled.

Is Epoetin Hospira SDV the same as other epoetin products?

Epoetin Hospira SDV is a specific single-dose vial formulation of epoetin developed by Pfizer. It is distinct from other epoetin products and formulations. The trial NCT03398473 specifically compared the single-dose vial (SDV) and multi-dose vial (MDV) presentations of Epoetin Hospira.