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Trial record 2 of 14 for:    pegfilgrastim biosimilar

A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03273842
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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]) 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: PF-06881894 Biological: US-approved Neulasta Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase 1, Randomized Open Label, Multiple Dose, Parallel Study To Assess The Immunogenicity Of Multiple Subcutaneous (SC) Doses Of The Proposed Pegfilgrastim Biosimilar (PF-06881894) And Us-approved Neulasta (Registered) In Healthy Volunteers
Actual Study Start Date : October 27, 2017
Actual Primary Completion Date : July 25, 2018
Actual Study Completion Date : July 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06881894
PF-06881894 6 mg SC
Biological: PF-06881894
pre-filled syringe 6 mg

Active Comparator: US-approved Neulasta
US-approved Neulasta 6 mg SC
Biological: US-approved Neulasta
pre-filled syringe 6 mg




Primary Outcome Measures :
  1. 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. [ Time Frame: 90 days (through Period 1 Day1 to Period 2 Day 60 or final visit) ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 90 Days (through Period 1 Day 1 to Period 2 Day 60 or final study visit) ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273842


Locations
United States, Florida
Seaview A Quotient Clinical Business
Coral Gables, Florida, United States, 33134
Quotient Sciences- Jacksonville, LLC
Jacksonville, Florida, United States, 32256
Seaview A Quotient Clinical Business
Miami, Florida, United States, 33126
United States, Kansas
Vince & Associates Clinical Research Inc.
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03273842     History of Changes
Other Study ID Numbers: C1221005
IMM HSP-130 ( Other Identifier: Alias Study Number )
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No