A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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 \[mg\]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1 of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two treatment periods. In addition, safety assessments will be conducted throughout the study.
Key facts
- Study ID
- NCT03273842
- Run by
- Pfizer
- People needed
- 422
- Starts
- 2017-10-27
- Expected to finish
- 2018-07-25
- Last updated by the study team
- 2018-09-05
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Seaview A Quotient Clinical Business — Coral Gables, Florida, United States
- Quotient Sciences- Jacksonville, LLC — Jacksonville, Florida, United States
- Seaview A Quotient Clinical Business — Miami, Florida, United States
- Vince & Associates Clinical Research Inc. — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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