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PF-06881894

Phase 1

Undisclosed | Monoclonal antibody | Other |Pfizer, Inc.|Trials Updated: Sep 5, 2018

PF-06881894 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment422

FDA Designations

No designations recorded

PF-06881894 clinical trials

PF-06881894 · 1 trial · 1 indication

Phase 1 1
NCT03273842A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy VolunteersHealthy Volunteers
COMPLETED422 Analytics
PHASE1COMPLETED
A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and confirmed postdose positive anti-pegfilgrastim antibody test result at any time during the study.
90 days (through Period 1 Day1 to Period 2 Day 60 or final visit)

Secondary Endpoints

The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and postdose positive neutralizing antibody result at any time during the study.
90 Days (through Period 1 Day 1 to Period 2 Day 60 or final study visit)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
PF-06881894EXPERIMENTALPF-06881894 6 mg SC
US-approved NeulastaACTIVE_COMPARATORUS-approved Neulasta 6 mg SC

Interventions

NameTypeDescription
PF-06881894BIOLOGICALpre-filled syringe 6 mg
US-approved NeulastaBIOLOGICALpre-filled syringe 6 mg
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: • Healthy males or females between 18 and 65 years of age (both inclusive) with body mass index between 19 and 30 kg/m2, inclusive, and body weight of not \<50 kg or \>95 kg, will be enrolled in this study. Exclusion Criteria: * Hematologic laboratory abnormalities (including ...

Countries:United States
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Frequently asked questions about PF-06881894

What is PF-06881894?

PF-06881894 is an investigational monoclonal antibody developed by Pfizer, Inc. (ticker PFE). It has been studied in healthy adult volunteers rather than in patients with a specific disease. The compound is in Phase 1 clinical development, and its therapeutic area and intended indications have not been publicly disclosed.

Who makes PF-06881894?

PF-06881894 is made and developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical study of the compound conducted in the United States. The asset remains an investigational agent in Pfizer's pipeline.

What phase is PF-06881894 in?

PF-06881894 is in Phase 1 clinical development. Its only listed trial, NCT03273842, was a Phase 1 study that has been completed. Because the program is still in early-stage clinical testing, PF-06881894 is investigational and has not been approved by the FDA for any use.

What clinical trials is PF-06881894 in?

PF-06881894 has been evaluated in one clinical trial, NCT03273842, titled A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers. The Phase 1 study enrolled 422 healthy volunteers in the United States, was active-controlled and randomized, and is now completed.

What does PF-06881894 target?

PF-06881894 is a monoclonal antibody, a modality in which the molecule is designed to bind a specific molecular target. The publicly available program information does not identify the exact target or target class for PF-06881894, so its precise mechanism of action has not been disclosed.

Is PF-06881894 the same as Neulasta?

No. PF-06881894 and US-approved Neulasta are separate products. In trial NCT03273842, PF-06881894 was compared against US-approved Neulasta as the active control in healthy volunteers, which means Neulasta served as the comparator arm rather than being the same molecule as PF-06881894.