Status:
COMPLETED
A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study compares the immune response to the proposed biosimilar PF-06881894 and the US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6 milligrams \[mg\]) eit...
Eligibility Criteria
Inclusion
- • 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
- Hematologic laboratory abnormalities (including leukocytosis \[defined as total leukocytes \>11,000/mcL\], leukopenia \[defined as total leukocytes \<4000/mcL\], or neutropenia \[defined as absolute neutrophil count \<1500/mcL\] or thrombocytopenia \[defined as platelet count of \<150,000/mcL\]) or other clinically significant abnormal laboratory evaluations.
- Lack of adequate hepatic or renal reserve.
- Any active systemic or immunologic disease or condition.
- History of biological growth factor exposure.
- Received live vaccination or exposure to communicable viral diseases within 4 weeks prior to Screening.
Key Trial Info
Start Date :
October 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2018
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT03273842
Start Date
October 27 2017
End Date
July 25 2018
Last Update
September 5 2018
Active Locations (4)
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1
Seaview A Quotient Clinical Business
Coral Gables, Florida, United States, 33134
2
Quotient Sciences- Jacksonville, LLC
Jacksonville, Florida, United States, 32256
3
Seaview A Quotient Clinical Business
Miami, Florida, United States, 33126
4
Vince & Associates Clinical Research Inc.
Overland Park, Kansas, United States, 66212