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PF-06881894

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Sep 5, 2018

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

Clinical trial landscape

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
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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 used for?

PF-06881894 is a monoclonal antibody being studied in healthy volunteers. It is currently in Phase 1 clinical development and is not approved for any indication. The drug is being investigated for its immune response effects in healthy individuals.

Who makes PF-06881894?

PF-06881894 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical trials to evaluate the drug's safety and immune response in healthy volunteers.

What phase is PF-06881894 in?

PF-06881894 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its immune response and safety profile.

What clinical trials is PF-06881894 in?

PF-06881894 has one completed Phase 1 clinical trial, NCT03273842, which assessed immune response to multiple doses of the drug compared to US-approved Neulasta in healthy volunteers. The trial enrolled 422 participants in the United States.

Is PF-06881894 the same as Neulasta?

PF-06881894 is not the same as Neulasta, but it is being compared to US-approved Neulasta in a clinical trial. The study NCT03273842 evaluated immune response to multiple doses of PF-06881894 or Neulasta in healthy volunteers.